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Pain Therapeutics Inc. Message Board

  • boorsrus boorsrus Aug 29, 2013 1:09 PM Flag

    Barbier on Remoxy

    Posted by BioWorld Today:

    Pain Therapeutics Inc. and Durect Corp. each enjoyed a stock surge when news got out that Pfizer Inc. began a new clinical trial of Remoxy (oxycodone) three months after the pharma had signaled that it was considering discontinuation of the product.

    Pain Therapeutics, of Austin, Texas, developed Remoxy using technology designed to discourage tampering. It licensed the drug from Cupertino, Calif.-based Durect in 2002, and in 2005, Pain Therapeutics licensed development and commercialization to King Pharmaceuticals Inc. The drug fell into Pfizer's hands through its acquisition of King.

    Pain Therapeutics stock (NASDAQ:PTIE) gained 34 percent Friday to close at $3.08, and Durect (NASDAQ:DRRX) surged 17 percent, closing at $1.23.

    Remi Barbier, CEO of Pain Therapeutics, told BioWorld Today, "We're not out of the woods until we get a definitive go/no-go letter from Pfizer." Pfizer committed to sending the letter by the time of the next quarterly earnings report, in about five or six weeks. "That's the real trigger for a number of investors," Barbier said.

    Barbier pointed out that it takes on average about 12 years to develop a drug. "Remoxy's pretty much on track with that unfortunate record," Barbier said. The FDA laid out a "crystal clear" road map for Pfizer to satisfy the agency's requirements for approval in May, according to Barbier, and that included "six or seven" clinical studies and some in vitro work. The agency did not require any new efficacy studies.

    "It's pretty straightforward," Barbier said. "Pfizer knows exactly what has to get done. We know exactly what has to get done."

    In a clinical trial announcement, Pfizer said it would carry out a trial to estimate the effects of food on oxycodone pharmacokinetics after administration of 40-mg doses of "formulation K" of the drug, and estimate its relative bioavailability compared to "formulation X" in fasted state in healthy volunteers.

    The food effect study is one of the studies laid out by the FDA for completion of Remoxy's application. "It's a good sign," Barbier said. "Kind of a flashing green light. Stay tuned. In about three weeks, we'll know exactly which way this will play out."

    Pfizer has issued guidance for a mid-2015 re-filing date for Remoxy, which puts potential approval around the end of 2015. "We have seen the road map that the FDA provided Pfizer," Barbier said. "It is not a difficult road map. The heavy lifting is behind us."

    After Pain Therapeutics developed Remoxy, a long-acting formulation of oxycodone, the firm submitted the initial new drug application (NDA) June 2008, and received a complete response letter in December 2008. (See BioWorld Today, May 13, 2013.)

    A few months after that, King assumed full control of development and resubmitted the NDA in December 2010.

    Pfizer picked up Remoxy in February 2011 , when it closed its $14.25 per share, $3.6 billion acquisition of King, now a wholly owned subsidiary of Pfizer. (See BioWorld Today, Oct. 13, 2010.)

    The Oxycontin market is estimated at about $3 billion annually, and even with a crush-resistant formulation of Oxycontin available from Purdue Pharma LP, there is a strong demand for new oxycodone formulations.

    Purdue's product is designed to prevent abusers from cutting, breaking, chewing, crushing or dissolving the narcotic to achieve an immediate high. However, addicts have found ways to get around those tamper-resistant properties.

    Oxycontin is formulated with a polymer that makes it difficult to crush or grind the tablets, but it is not impossible to abuse. Remoxy, on the other hand, is a gelatin capsule filled with a Vaseline-like substance with a thick consistency that is hard to dissolve and hence highly resistant to abuse. It is also too viscous to inject.

    Pain Therapeutics lost 22 cents, to close at $2.89 Monday. Durect lost 5 cents, closing at $1.18.

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