Abuse-Resistant Pain Drug Resubmitted for Approval

The abuse-resistant pain reliever Remoxy, manufactured by King Pharmaceuticals and Pain Therapeutics Inc., is being resubmitted to the FDA for approval.

The experimental drug was originally submitted to the FDA in 2008, however, it recieved a complete response letter. The FDA sought more proof that the drug decreased abuse.

The experimental drug is designed to treat moderate to severe pain for 24 hours. It is to be adminstered twice daily and may be used long-term. The drug uses ORADUR technology, which works to alter the short-acting oral capsule dosage to allow sustained release. In addition, the drug product is resistant to popular methods of prescription drug misuse and abuse.

According to a press release, Remoxy was developed by Pain Therapeutics to help address the growing problem of non—medical use of prescription opioids. Remoxy is comprised of a high–viscosity, liquid formulation in a hard gelatin capsule that is designed to provide steady, around–the–clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.

King pharmaceuticals develops novel branded prescription pharmaceutical products and technologies. The company focuses on specialty—driven markets, particularly neuroscience and hospital.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to Remoxy, the company has three other drug candidates in clinical programs. These include a novel monoclonal antibody—based treatment against metastatic melanoma. The Company is also developing a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding.

Source: King Pharmaceuticals--Will the drug recieve approval? Leave a comment.