<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01666119</url>
  </required_header>
  <id_info>
    <org_study_id>BNX-201</org_study_id>
    <nct_id>NCT01666119</nct_id>
  </id_info>
  <brief_title>An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects</brief_title>
  <official_title>An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (BNX-201)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioDelivery Sciences International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioDelivery Sciences International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label study in opioid dependent subjects maintained on a stabilized dose of&#xD;
      Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA&#xD;
      Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized&#xD;
      on Suboxone (buprenorphine/naloxone) tablets or films.&#xD;
&#xD;
      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.&#xD;
      This dose will be taken throughout the 12-week treatment period with dose adjustments as&#xD;
      clinically indicated for either the control of opioid dependence or adverse events (AEs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label study in opioid dependent subjects maintained on a stabilized dose of&#xD;
      Suboxone tablets or films.&#xD;
&#xD;
      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.&#xD;
      This dose will be taken throughout the 12-week treatment period with dose adjustments as&#xD;
      clinically indicated for either the control of opioid dependence or adverse events (AEs).&#xD;
      Subjects will be monitored for evidence of buccal irritation attributed to the application of&#xD;
      the BEMA Buprenorphine NX film and opioid dependence control according to the Clinical&#xD;
      Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction - A Treatment&#xD;
      Improvement Protocol (TIP 40) guidelines for the use of buprenorphine in the management of&#xD;
      opioid dependence.&#xD;
&#xD;
      The total duration of participation for each subject will be up to approximately 18 weeks and&#xD;
      includes a Screening period (subjects continue to take Suboxone tablets or films), Baseline&#xD;
      visit, a 12-week open label treatment period (subjects take BEMA Buprenorphine NX films and&#xD;
      at the Day 84 visit, subjects will return to their prior Suboxone treatment), and a Follow-up&#xD;
      Visit.&#xD;
&#xD;
      Vital signs, pulse oximetry, opioid withdrawal symptoms, adverse events (AEs), oral&#xD;
      examinations, and concomitant medications will be assessed at intervals throughout the study.&#xD;
      Clinical laboratory assessments, urine toxicology and buprenorphine testing, and 12-lead&#xD;
      electrocardiograms (ECGs) will also be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in &gt; 2 subjects, the total number of unique events that were experienced are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine Drug Screen</measure>
    <time_frame>12 weeks</time_frame>
    <description>Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">249</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>BEMA Buprenorphine NX films</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BEMA Buprenorphine NX films</intervention_name>
    <description>BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.</description>
    <arm_group_label>BEMA Buprenorphine NX films</arm_group_label>
    <other_name>BNX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent obtained at Screening, prior to any study procedure being&#xD;
             performed&#xD;
&#xD;
          2. Male or non-pregnant and non-nursing female. A female of childbearing potential is&#xD;
             eligible to participate in this study if she is not pregnant, and is using an&#xD;
             acceptable method of birth control&#xD;
&#xD;
          3. Subject is aged 18 to 65 years of age, inclusive&#xD;
&#xD;
          4. Diagnosis of opioid dependence per the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders - 4th edition (text revision) (DSM-IV-TR) criteria in the past 12 months&#xD;
             including physical dependence on opioids and addiction with compulsive use despite&#xD;
             harm&#xD;
&#xD;
          5. Currently taking a stable, single daily dose of 16/4 to 32/8 mg Suboxone tablets or&#xD;
             films (buprenorphine/naloxone) for at least 30 days&#xD;
&#xD;
          6. Subject is in good general health; with no clinically significant findings on medical&#xD;
             history, physical examination, safety laboratory test and ECG in the judgment of the&#xD;
             investigator at screening. Serum creatinine, alanine aminotransferase (ALT), and&#xD;
             aspartate aminotransferase (AST) values must be within 3-times the upper limit of&#xD;
             normal (ULN). Pulse oximetry must be ≥96%, systolic blood pressure ≥110 mmHg, and&#xD;
             diastolic blood pressure ≥65 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypokalemia, hypomagnesemia, or clinically unstable cardiac disease, including:&#xD;
             unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart&#xD;
             failure, active myocardial ischemia, or clinically significant arrhythmias&#xD;
&#xD;
          2. History of Long QT Syndrome, or an immediate family member with this condition&#xD;
&#xD;
          3. Currently taking Class IA antiarrhythmic medications (eg, quinidine, procainamide,&#xD;
             disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone,&#xD;
             dofetilide)&#xD;
&#xD;
          4. Uncontrolled hypertension defined as systolic blood pressure &gt;170 mmHg and diastolic&#xD;
             blood pressure &gt;90 mmHg at Baseline&#xD;
&#xD;
          5. Pulse oximetry ≤93% at Baseline, regardless of cause&#xD;
&#xD;
          6. Clinically significant abnormality on 12-lead ECG, including a QTc interval &gt;490&#xD;
             milliseconds&#xD;
&#xD;
          7. Use of any medication, nutraceutical or herbal product with CYP3A4 inhibition or&#xD;
             induction properties within the past 30 days (see Appendix 4 for a list of applicable&#xD;
             drugs). This exclusion also extends to grapefruit juice and grapefruit&#xD;
             juice-containing products as well as St. John's wort and St. John's wort-containing&#xD;
             products (prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal&#xD;
             supplements).&#xD;
&#xD;
          8. Diagnosis of moderate to severe hepatic impairment&#xD;
&#xD;
          9. Use of an investigational drug or device within the last 30 days&#xD;
&#xD;
         10. Participation in a previous clinical study of BEMA Buprenorphine NX or BEMA&#xD;
             Buprenorphine&#xD;
&#xD;
         11. History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or&#xD;
             related drugs&#xD;
&#xD;
         12. Pierced tongue or mouth&#xD;
&#xD;
         13. Any clinically significant abnormality of the buccal mucosa which could impact drug&#xD;
             absorption&#xD;
&#xD;
         14. Suicidal risk, as determined by meeting any of the following:&#xD;
&#xD;
               1. History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4&#xD;
                  (intent to act) or 5 (specific plan and intent) on the eC-SSRS&#xD;
&#xD;
               2. History of suicidal behavior ≤ 1 year prior to Baseline (actual attempt,&#xD;
                  interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the&#xD;
                  eC-SSRS&#xD;
&#xD;
         15. A history or current evidence of any clinically significant disorder or any other&#xD;
             condition which in the opinion of the investigator, would jeopardize the safety of the&#xD;
             subject or impact the validity of the study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Greg Sullivan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parkway Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haleyville</city>
        <state>Alabama</state>
        <zip>35565</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belvidere</city>
        <state>New Jersey</state>
        <zip>07823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>February 2, 2015</results_first_submitted>
  <results_first_submitted_qc>February 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2017</results_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid dependence</keyword>
  <keyword>Suboxone</keyword>
  <keyword>addiction</keyword>
  <keyword>BEMA Buprenorphine NX</keyword>
  <keyword>oral transmucosal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BEMA Buprenorphine NX Films</title>
          <description>BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).&#xD;
BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="249"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>non compliance with study medication, pa</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject experiencing withdrawal symptoms</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BEMA Buprenorphine NX Films</title>
          <description>BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.&#xD;
BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="249"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.7" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Urine Drug Screen</title>
        <description>Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.</description>
        <time_frame>12 weeks</time_frame>
        <population>Subjects with at least one urine drug screen test during the treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>BEMA Buprenorphine/NX Films</title>
            <description>BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Drug Screen</title>
          <description>Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.</description>
          <population>Subjects with at least one urine drug screen test during the treatment period.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="249"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with +-result for non-prescribed opiod</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number with single positive result</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number with 2 positive results</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number with &gt; 2 positive results</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events</title>
        <description>Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in &gt; 2 subjects, the total number of unique events that were experienced are reported.</description>
        <time_frame>12 weeks</time_frame>
        <population>All subjects who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>BEMA Buprenorphine/NX Films</title>
            <description>BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in &gt; 2 subjects, the total number of unique events that were experienced are reported.</description>
          <population>All subjects who received at least 1 dose of study drug.</population>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="249"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>BEMA Buprenorphine NX Films</title>
          <description>BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.&#xD;
BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Medra</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="249"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="249"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="249"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>Medra</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="89" subjects_at_risk="249"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>drug withdrawal syndrome</sub_title>
                <counts group_id="E1" events="89" subjects_affected="89" subjects_at_risk="249"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Enoch Bortey</name_or_title>
      <organization>BDSI</organization>
      <phone>919 582 9050</phone>
      <email>ebortey@bdsi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01666119
org study id: BNX-201
nct id: NCT01666119
lead sponsor: 
has dmc: No
This is an open label study in opioid dependent subjects maintained on a stabilized dose of
      Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA
      Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized
      on Suboxone (buprenorphine/naloxone) tablets or films.

      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.
      This dose will be taken throughout the 12-week treatment period with dose adjustments as
      clinically indicated for either the control of opioid dependence or adverse events (AEs).
This is an open label study in opioid dependent subjects maintained on a stabilized dose of
      Suboxone tablets or films.

      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.
      This dose will be taken throughout the 12-week treatment period with dose adjustments as
      clinically indicated for either the control of opioid dependence or adverse events (AEs).
      Subjects will be monitored for evidence of buccal irritation attributed to the application of
      the BEMA Buprenorphine NX film and opioid dependence control according to the Clinical
      Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction - A Treatment
      Improvement Protocol (TIP 40) guidelines for the use of buprenorphine in the management of
      opioid dependence.

      The total duration of participation for each subject will be up to approximately 18 weeks and
      includes a Screening period (subjects continue to take Suboxone tablets or films), Baseline
      visit, a 12-week open label treatment period (subjects take BEMA Buprenorphine NX films and
      at the Day 84 visit, subjects will return to their prior Suboxone treatment), and a Follow-up
      Visit.

      Vital signs, pulse oximetry, opioid withdrawal symptoms, adverse events (AEs), oral
      examinations, and concomitant medications will be assessed at intervals throughout the study.
      Clinical laboratory assessments, urine toxicology and buprenorphine testing, and 12-lead
      electrocardiograms (ECGs) will also be performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: 12 weeks
description: Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.
measure: Urine Drug Screen
time frame: 12 weeks
description: Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.
arm group label: BEMA Buprenorphine NX films
arm group type: Experimental
description: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
intervention type: Drug
intervention name: BEMA Buprenorphine NX films
description: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
arm group label: BEMA Buprenorphine NX films
other name: BNX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Greg Sullivan, MD
role: Principal Investigator
affiliation: Parkway Medical
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 