Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
Remoxy ER is a new formulation of oral oxycodone designed to deter abuse but still provide 12 hours of pain relief. The formulation has a thick, sticky, high viscosity, hydrophobic, gel formulation that prevents possible drug abusers from cutting, grating or dividing the drug into smaller particle sizes. It is also resistant to being modified to be injected.
A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14 to 3 against approval.
The company filed its first new drug application (NDA) for Remoxy ER in June 2008, and received its first complete response letter (CRL) from the FDA in December of that year. Then, a few months later, Pain Therapeutics signed a deal related to Remoxy ER with King Pharmaceutical, which resubmitted the NDA in December 2010. The following February 2011, Pfizer acquired King Pharma, picking up Remoxy ER in the process.
In June 2011, the FDA rejected Remoxy again, and Pfizer indicated it planned to resolve the issues outlined in the CRL. Instead, it abandoned the drug in 2014, giving the rights back to Pain Therapeutics.
In 2016, the FDA rejected it again, indicating the “NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.”
Pain Therapeutics at the time stated that the CRL’s focus was on abuse deterrence and had proposed drug labeling. There was no mention of safety, efficacy, manufacturing or any biopharmacological issues.
The vote is a bit of a surprise given the current emphasis on coming up with solutions to fight the opioid epidemic, but the drug’s history also suggests the problems are extensive.
The PDUFA target action date for the drug is August 7. The FDA does not have to follow the recommendations of the Advisory Committee, but it usually does.
Pain Therapeutics licensed the rights to Remoxy ER from Durect Corporation, based in Cupertino, California. Pain Therapeutics is located in Austin, Texas.
In its first-quarter financial report, Pain Therapeutics reported a new loss of $2.2 million or $0.33 per share. It ended the quarter with cash and cash equivalents of $10.7 million compared to $10.5 million in the previous quarter.
The company has other early-stage candidates in its pipeline, including PTI-125, an oral, small molecule candidate designed in-house. It is designed to treat Alzheimer’s disease. It is in a Phase I clinical stage program, funded in large part by a grant from the National Institutes of Health (NIH). It has Fenrock (transdermal fentanyl patch system), also in an early-stage program, funded by grants from the National Institute on Drug Abuse (NID). PTI-125DX is a proprietary blood-based test to detect Alzheimer’s disease.
