Pain Therapeutics Inc. (PTIE) recently presented top-line data on its pain candidate Remoxy from an abuse liability study.
“Drug Liking” Lower in Remoxy Arm
The double blind, placebo and active-controlled, six-way crossover study was conducted to evaluate the abuse potential of Remoxy. Results showed that “drug liking” was significantly lower in the Remoxy 40 mg (whole) arm compared to oxycodone ER 40 mg (whole) or oxycodone IR 40 mg.
Pain Therapeutics also said that “drug liking” was significantly lower in the Remoxy 40 mg (chewed) arm compared to oxycodone ER 40 mg (crushed) or oxycodone IR 40 mg.
Moreover, the “time to peak drug liking” was delayed significantly in the Remoxy 40 mg (chewed) arm compared to oxycodone ER 40 mg (crushed) or oxycodone IR 40 mg.
Pain Therapeutics said that the unpleasant taste/texture of Remoxy made it difficult for patients to chew the candidate for more than 1.5 minutes despite being allotted 10 minutes for the same.
FDA Action Date: June 23, 2011
Remoxy is currently under US Food and Drug Administration (FDA) review. Pain Therapeutics re-submitted a new drug application (NDA) to the FDA for the candidate in December 2010. Remoxy has been developed, using Durect Corporation’s (DRRX) ORADUR technology, for moderate to severe pain that requires continuous, round-the-clock opioid treatment for an extended period of time.
The re-submission is being treated as a Class II review with a response expected by June 23, 2011. The initial NDA for Remoxy was submitted in June 2008. However, in late December 2008, the FDA issued a complete response letter asking for additional information. As part of the resubmission plan and in order to strengthen the NDA, a likeability study and a pharmacokinetic trial was conducted in volunteers.
Pain Therapeutics has a commercialization agreement with Pfizer, Inc. (PFE) for Remoxy and three other abuse-resistant prescription opioid candidates. Remoxy became a part of Pfizer’s portfolio following its acquisition of King Pharmaceuticals.
We believe that Remoxy will eventually receive approval given the need for abuse-deterrent products in the pain management market. We currently have a Neutral recommendation on Pain Therapeutics, supported by a Zacks #3 Rank (short-term “Hold” rating). Pain Therapeutics intends to present results from this study at the annual meeting of the American Pain Society in May 2011.
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