(Updates with additional information and comments throughout including FDA comments starting in fourth paragraph.)
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The majority of members on a Food and Drug Administration advisory panel said a proposed pain pill by Pain Therapeutics Inc. (PTIE) was likely to be less susceptible to abuse and misuse than similar pain pills on the market.
Pain Therapeutics of San Mateo, Calif., developed a drug, Remoxy, which is a controlled-release form of the painkiller oxycodone with features designed to resist common methods of abuse such as crushing or dissolving a tablet in order to get the entire dose of the drug at once. Although the panel didn't take a formal vote on the product, 11 members said the data submitted by the company suggests Remoxy is abuse resistant while 8 members said the data didn't meet the threshold.
If approved the drug would be sold by King Pharmaceuticals Inc. (KG) of Bristol, Tenn. The FDA usually follows its panels advice but is not required to. The agency is expected to make a decision on Remoxy by Dec. 10.
But FDA approval of the product is far from certain. Bob Rappaport, the director of the FDA drug division that review pain products, said that agency is "struggling" to find the appropriate threshold to use in order to approve a pain product that appears harder to abuse.
A controlled-release form of oxycodone is currently sold as OxyContin by Purdue Pharma LP, a privately held firm in Stamford, Conn., but the drug has been linked to a rise in prescription drug-abuse rates as some abusers crush the drug or dissolve it in alcohol and inject it to get all the effects at once, creating a heroin-like high. The product is supposed to be swallowed whole and is meant to release the pain medicine over 12 hours.
The FDA has encouraged drug companies to develop new formulations of controlled-release oxycodones that might deter abuse but so far there isn't such a product on the market.
"Unfortunately, successful new formulations have been elusive due to difficulties related to manufacturing, biopharmaceutical concerns and clinical failures in early studies," the agency said in a memo prepared for the panel meeting.
The issue isn't whether Remoxy works to treat pain; it's whether the drug could be approved and labeled as a product that could cut abuse.
Remoxy is a capsule with a liquid that is designed to resist crushing, injection or snorting. Pain Therapeutics conducted a set of studies suggesting the product is harder to tamper with than an OxyContin tablet and that all the oxycodone isn't immediately released when it's submerged in alcohol, for example.
But, Ping Ji, an FDA senior clinical pharmacologist, said Remoxy's extended release mechanism was compromised when the product was chewed or allowed to absorb in the mouth.
Nadav Friedmann, Pain Therapeutics's chief medical officer, said the amount of active ingredient released in those situations was far below that of OxyContin and an oral solution of oxycodone used in testing.
"Remoxy did not immediately release a significant portion of its dose," he said. Dr. Friedmann conceded that more of the drug would be released the longer it was submerged in alcohol or placed in a person's mouth, for example.
"This drug is designed to treat patients in pain and resist common methods of abuse," he said. "The common use is someone who wants to get high immediately."
However, several panel members, including Jack Rosenberg, a doctor from the University of Michigan, said that before the product is approved, the FDA should require it to be studied in a group of drug abusers to see if the product really did deter abuse.
Sidney Wolfe, a panel member and the director of Public Citizen's health research group, said he was concerned about how Remoxy would be marketed if abuse claims were allowed in the label.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.
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(END) Dow Jones Newswires
November 13, 2008 17:34 ET (22:34 GMT)

Publié le 13 novembre 2008 Copyright © 2008 Dowjones