Dive Brief:
- Pain Therapeutics plans to regroup with the U.S. Food and Drug Administration following the agency’s latest — and third — rejection of its pain drug Remoxy ER (oxycodone capsules CII), the company said Monday.
- The Austin,TX-based company expects to discuss the drug’s abuse-deterrent properties and labeling, highlighted as still-to-be-overcome problems in the agency’s complete response letter (CRL).
- The company says it expects to spend as much as $5 million and take a year to meet the agency’s demands.
Dive Insight:
Pain Therapeutics, which obtained the exclusive right from Durect to develop the oxycodone-based Remoxy ER, is still optimistic that it can win approval of the drug despite many setbacks.
Peter S. Roddy, the company’s vice president & chief financial officer, said while the company resolved previous FDA concerns over the drug, it keeps running into new obstacles. In a call with investors, Roddy described the latest FDA letter as a "speed bump, not a death blow. We have the cash, perseverance, and knowledge to move forward." He questioned why the FDA didn’t grant an extension, rather than the flat-out rejection.
Remoxy ER is an oxycodone-containing extended-release capsule based on Durect’s Oradur technology, which the company said is designed to discourage common methods of tampering associated with opioid use and misuse.
The federal agency’s latest action comes as it tackles an opioid drug abuse epidemic which it has flagged as a critical health problem. Nearly 19,000 people died from opioid abuse in 2014, according to the National Institutes of Health.
Pain Therapeutics had sought to win a label claim promoting Remoxy's resistance to abuse by chewing. The FDA didn't buy the company's evidence, however, and also asked for further studies to be conducted to prove further abuse deterrence.
The FDA is particularly sensitive to marketing of drugs that may be misinterpreted by patients. Earlier this month, the agency sent a letter to Pain Therapeutics and Durect, criticizing the companies for improper marketing statements about the still unapproved drug.
As the company moves forward in discussions with the FDA, it is likely to focus attention on what additional actions are needed for approval, especially involving label claims against what has been termed three routes of abuse — injection, inhalation and snorting — as spelled out by the CRL. Pain Therapeutics said it will conduct studies in each area to compare Remoxy ER against one or more approved oxycodone ER drug products.
Pain Therapeutics initially planned to include four label claims for FDA approvals, but Roddy said that plan might have been unrealistic.
The drug was formerly owned by drug giant Pfizer after its acquisition of King Pharmaceuticals, but the company abandoned Remoxy after approval seemed like a lost cause.