Pain Therapeutics, Inc. (PTIE), said Monday an abuse liability study of its investigational pain relief drug Remoxy met all primary endpoints - patients on Remoxy showed lower liking for the drug compared with standard care oxycodone and placebo.
Currently, a New Drug Application for Remoxy is under regulatory review, with a target PDUFA date of June 23, 2011. Pfizer Inc. (PFE) is Pain Therapeutics' exclusive commercial partner for Remoxy and also for three other abuse-resistant prescription pain medications.
Remoxy is an encapsulated, water insoluble, twice-daily oral formulation of oxycodone, which is a narcotic medication. The drug is intended to address problems of prescription drug abuse.
According to California-based Pain Therapeutics, Remoxy is designed to provide steady pain relief, while resisting common methods of abuse that result in 'dose-dumping', or the rapid, premature release of a large dose of oxycodone.
The abuse liability study evaluated the abuse potential of Remoxy relative to oxycodone extended-release (ER), oxycodone immediate release (IR) and placebo.
The double blind, placebo and active-controlled study enrolled 45 healthy adults with histories of non-dependent recreational opiod use. The study assessed the abuse potential of Remoxy 40 mg whole and chewed, oxycodone ER 40 mg whole and crushed, oxycodone IR 40 mg crushed and placebo.
Results showed that 'Drug Liking' was significantly lower for Remoxy 40mg (whole) compared with oxycodone ER 40mg (whole) or oxycodone IR 40 mg. Drug Liking was significantly lower for Remoxy 40mg (chewed) compared with oxycodone ER 40mg (crushed) or oxycodone IR 40 mg.
PTIE is trading at $9.07, up $0.25 or 2.83%, on a volume of 0.28 million shares on the Nasdaq.
PFE is trading at $20.13, up $0.34 or 1.72%, on a volume of 28.4 million shares on the NYSE.
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