FDA Asks if Pain Pill Is Tamper-Proof
By JENNIFER CORBETT DOOREN - NOVEMBER 11, 2008
online.wsj.com
A Food and Drug Administration memo Monday questioned whether a proposed pain pill by Pain Therapeutics Inc. and King Pharmaceuticals Inc. is tamper-resistant.
Pain Therapeutics of San Mateo, Calif., developed a drug, Remoxy, that is a controlled-release form of the painkiller oxycodone with features that are designed to resist common methods of abuse, including crushing or dissolving a tablet in order to get the entire dose of the drug at once.
If approved, the drug would be sold by King Pharmaceuticals of Bristol, Tenn.
A controlled-release form of oxycodone is currently sold as OxyContin by Purdue Pharma LP, a privately held company in Stamford, Conn., but the drug has been linked to a rise in prescription-drug-abuse rates because some users crush the drug or dissolve it in water 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.
Remoxy faces a review Thursday by an FDA panel of outside medical experts. Another drug, Embeda, which is a controlled-release form of morphine from Alpharma Inc., Bridgewater, N.J., faces a panel review Friday.
Embeda combines morphine with naltrexone, which limits the effectiveness of morphine because both chemicals act on the same receptors in the brain if the pill is broken or tampered with.
If swallowed as directed, the naltrexone component is designed to stay inside the tablet and then pass through the gastrointestinal tract, thereby allowing the morphine to act as intended.
Remoxy is a capsule with a liquid that is designed to resist crushing, injection or snorting. Pain Therapeutics conducted a set of studies, including ones that tested whether submerging the pill in alcohol would release the contents of the drug.
The FDA didn't release a detailed review of Remoxy ahead of the panel meeting in order to maintain confidentiality about the chemistry and properties of the proposed formulation. An Embeda review is scheduled for release on Wednesday.
A memo from an FDA reviewer said Pain Therapeutics didn't attempt to determine the long-term extractability of oxycodone from Remoxy, saying the company studied the capsule by placing it in alcohol and other substances for as long as an hour.
Remi Barbier, Pain Therapeutics chief executive, took issue with the memo, saying the company did submit longer-term data to the agency that will be discussed at the panel meeting.
Write to JenniferCorbett Dooren at jennifer.corbett-dooren@dowjones.com |
