The reasoning for this requirement is that trial participants temporarily experienced sedation, visual disturbances, trouble speaking, confusion, numbness, and feelings of dizziness during immediately after. The approval of esketamine for TRD by the FDA was controversial due to limited and mixed evidence of efficacy and safety. In January 2020, esketamine was rejected by the National Health Service (NHS) of Great Britain. The NHS questioned the benefits of the medication for depression and claimed that it was too expensive. People who have been already using esketamine were allowed to complete treatment if their doctors considered this necessary.Spravato debuted to a cost of treatment of US$32,400 per year when it launched in the United States in March 2019. The Institute for Clinical and Economic Review (ICER), which evaluates cost effectiveness of drugs analogously to the National Institute for Health and Care Excellence (NICE) in the United Kingdom, declined to recommend esketamine for depression due to its steep cost and modest efficacy, deeming it not sufficiently cost-effective.Esketamine is the second drug to be approved for TRD by the FDA, following olanzapine/fluoxetine (Symbyax) in 2009. Other agents, like the atypical antipsychotics aripiprazole (Abilify) and quetiapine (Seroquel), have been approved for use in the adjunctive therapy of MDD in people with a partial response to treatment. In a meta-analysis conducted internally by the FDA during its evaluation of esketamine for TRD, the FDA reported a standardized mean difference (SMD) of esketamine for TRD of 0.28 using the three phase 3 short-term efficacy trials conducted by Janssen.
Mafenide (INN; usually as mafenide acetate, trade name Sulfamylon) is a sulfonamide-type medication used as an antibiotic. It was approved by the FDA in 1948. Uses
Mafenide is used to treat severe burns. It is used topically as an adjunctive therapy for second- and third-degree burns. It is bacteriostatic against many gram-positive and gram-negative organisms, including Pseudomonas aeruginosa. Some sources state that mafenide is more appropriate for non-facial burns, while chloramphenicol/prednisolone or bacitracin are more appropriate for facial burns. Mechanism of action
Mafenide works by reducing the bacterial population present in the avascular tissues of burns and permits spontaneous healing of deep partial-thickness burns. Adverse reactions
Adverse reactions can include superinfection, pain or burning upon application, rash, pruritus, tachypnea, or hyperventilation. Mafenide is metabolized to a carbonic anhydrase inhibitor, which could potentially result in metabolic acidosis. Drug interactions
There are no significant interactions. Contraindications
Mafenide is contraindicated in those with sulfonamide hypersensitivity or renal impairment. Dosage
For use as adjunctive therapy for second- and third-degree burns to prevent infection, adults and children should apply topically to a thickness of approximately 1.6 mm to cleaned and debrided wound once or twice per day with a sterile gloved hand. The burned area should be covered with cream at all times. References
External links
Mafenide information on RxList