(Updates with information on Embeda, another drug facing FDA panel review, starting in fourth paragraph.) By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- A Food and Drug Administration medical reviewer Monday questioned whether a proposed pain pill by Pain Therapeutics Inc. (PTIE) and King Pharmaceuticals Inc. (KG) was tamper-resistant.
Pain Therapeutics of San Mateo, Calif., developed a drug, Remoxy, which is a 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.
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 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 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 Thursday review by an FDA panel of outside medical experts while another drug, Embeda, that's a controlled release form of morphine from Alpharma Inc., Bridgewater, N.J., (ALO) 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, 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 Wednesday.
A memo from an FDA reviewer said Pain Therapeutics did not attempt to determine the long-term extractability of oxycodone from Remoxy. The companies studied the capsule by placing it in alcohol and other substances for up to an hour.
"In the absence of this information it is not possible to make conclusions regarding the tamper-resistant properties of the formulation," the memo said.
But Remoxy is being reviewed under the FDA's priority review mechanism, which the agency reserves for products it believes are an advance over existing products or when no approved product exists. Embeda also has priority review.
Earlier this year, a similar FDA panel reviewed a proposed OxyContin formulation that was also designed to be tamper-resistant. At the time the FDA said the proposed formulation didn't entirely prevent crushing or injecting.
Pain Therapeutics and King Pharmaceuticals said studies of Remoxy showed that it resisted dose dumping or rapid extraction when physically manipulated or chemically challenged and that it resisted manipulations performed in an attempt to modify the formulation to facilitate alternative routes of delivery such as snorting, injection or inhalation.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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(END) Dow Jones Newswires
November 10, 2008 17:08 ET (22:08 GMT)

Publié le 10 novembre 2008 Copyright © 2008 Dowjones