Omadacycline, sold under the brand name Nuzyra,  is a broad spectrum antibiotic medication belonging to the aminomethylcycline subclass of tetracycline antibiotics. In the United States, it was approved in October 2018, for the treatment of community-acquired bacterial pneumonia and acute skin and skin structure infections. In vitro studies
In vitro studies have shown that omadacycline has activity against a broad range of Gram-positive and select Gram-negative pathogens. Omadacycline has potent in vitro activity against Gram-positive aerobic bacteria including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant and multi-drug resistant Streptococcus pneumoniae, and vancomycin-resistant Enterococcus. Omadacycline also has antimicrobial activity against common Gram-negative aerobes, some anaerobes, and atypical bacteria such as Legionella and Chlamydia. This activity translated to potent efficacy for omadacycline in an in vivo systemic infection model in mice.Additional in vitro and in vivo studies of omadacycline metabolism, disposition, and drug interactions show that omadacycline is metabolically stable (i.e., it does not undergo significant biotransformation) and neither inhibits nor interacts with metabolizing enzymes or transporters. Mechanism of action
The mechanism of action of omadacycline is similar to that of other tetracyclines – inhibition of bacterial protein synthesis. Omadacycline has activity against bacterial strains expressing the two main forms of tetracycline resistance (efflux and ribosomal protection). Clinical trials
A phase II study was conducted comparing the safety and efficacy of omadacycline to linezolid for the treatment of complicated skin and skin structure infections.
Commercialization
Manufacturing process
Clocortolone is synthesized by the reaction of 6α-fluoro-16α-methyl-21-hydroxy-1,4,9(11)-pregnatriene-3,20-dione with tert-butyl hypochlorite. Commercialization history
The synthesis of clocortolone was invented and patented by Emanuel Kaspar and Rainer Philippson in 1973 with United States Patent 3,729,495. The original assignee of the patent was Schering AG, a research-centered German pharmaceutical company. The rights to Clocortolone were then sold to Germapharm, and then to Coria Laboratories, Ltd. of DFB Pharmaceuticals, Inc., a Fort Worth-based pharmaceutical company. Coria Laboratories, Ltd., the dermatology division of DFB Pharmaceuticals, Inc., was then sold to Valeant Pharmaceuticals in 2008. In 2011, Promius Pharma, LLC, an affiliate of Dr. Reddys Laboratories, and Valeant Pharmaceuticals International, Inc. announced that they had signed a joint agreement for Cloderm. Per this collaborative agreement, Promius Pharma made an upfront payment will continue to pay royalties as the consideration for the right to manufacture, distribute and market Cloderm in the United States. Price listing
In August 2016 Cloderm Cream 0.1% clocortolone pivalate was priced at $3.64 per gram and $140.98 per 45 gm tube. See also
Budesonide


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