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The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Shares of King Pharma (NYSE:KG) have gained about 35% since I wrote about the Company in late March as a value play on pending new drug approvals. Below are updates on three new pain drug candidates from King's quarterly results and business update today.
Embeda (morphine + naltrexone) has a pending NDA for proposed use as a pain drug that is designed to deter abuse and diversion. During 1Q09, KG received feedback from the FDA regarding a Risk Evaluation and Mitigation Strategy (REMS) for Embeda and is in discussions with the agency. KG remains confident that Embeda will be approved in the near future.
The Acurox (oxycodone + niacin) NDA has a priority review (six-month) designation by the FDA along with Acura Pharma (NASDAQ:ACUR) with a PDUFA decision date of 6/30/09. Acurox is an immediate release opioid analgesic with a proposed indication for the relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse.
During 1Q09, KG assumed full control from Pain Therapeutics (NASDAQ:PTIE) of all activities related to the development of Remoxy, which is a long-acting oxycodone formulation designed to deter abuse and misuse. KG has set a new date with the FDA in the first half of July 2009 to discuss the Complete Response Letter (CRL) issued by the agency in December 2008 to clarify the non-clinical information required to gain approval for Remoxy.
Disclosure: No positions.
