Pain Therapeutics says Remoxy has 'clear runway' to approval

By Jennifer Lanning Drey

Eugene, Ore., June 15 - Pain Therapeutics, Inc. believes Remoxy, its abuse-resistant opioid painkiller under development, has "a clear runway" to approval from the Food and Drug Administration, according to Remi Barbier, president and chief executive officer of the company.

The drug received a special protocol assessment from the FDA earlier this year and enrollment in phase 3 trials is on track, said Barbier during a presentation made Thursday at the Needham & Co. Biotechnology and Medical Technology Conference.

Pain Therapeutics expects to report clinical results from the trial by the first half of 2007 and file a New Drug Application in late 2007 or early 2008, he said.

The company believes if brought to the market, the drug's advantage over other opioid painkillers that are already available would be its non-abusive qualities, Barbier said.

"Today's painkillers, by and large, are exact replicas of the opioid painkillers that our great, great grandparents used," he said.

Remoxy is a twice-daily version of OxyContin that is engineered to maintain its time-release qualities when crushed. The time-release mechanism in other versions of OxyContin is breached when the drug is crushed, making them easier to abuse, Barbier said.

In addition, Remoxy is not absorbed when mixed with alcohol, he said.

Restarting Oxytrex phase 3

Pain Therapeutics also plans to initiate two phase 3 trials of Oxytrex, another investigational opioid painkiller, before the end of the year, Barbier said.

The company was encouraged by a strategic meeting held during the first quarter with the Food and Drug Administration to discuss the feasibility of Oxytrex's approval, Barbier said.

"The feedback they gave us was very positive insofar as they highly encouraged the ongoing development of Oxytrex," he said.

A previous phase 3 trial of Oxytrex failed when the drug did not meet its primary endpoint of statistical significance due to a high dropout rate in all study arms. There were no meaningful statistical values gained in the study, Barbier said Thursday.

The primary endpoint in the new phase 3 clinical trial, which is on track to begin in December, will be physical dependence, he said.

Oxytrex is designed to avoid symptoms of physical dependence when a patient stops taking the drug.

Pain Therapeutics is currently discussing the specifics of its upcoming phase 3 trial with the FDA. The company said it would aim for a broad label approval.

Pain Therapeutic expects the market for both of its drug candidates to grow because of the aging population, which is likely to be exposed to chronic illnesses, he said.

Pain Therapeutics is a South San Francisco, Calif., biopharmaceutical company with drug candidates that target different types of chronic pain.

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