Regulators Denies Pfizer’s Pain Drug

Pfizer-FDA-062411.jpgRegulators today rejected the Pfizer Inc. pain drug that was designed to discourage abuse.

The New York drug maker said that more information’s were asked about the drug Remoxy by the Food and Drug Administration and thus the approval of Remoxy could be delayed because of issues with the manufacturing part of its application. The companies shares fell by 8 cents to $20.57 in trading.

Shares of Pfizer’s partners on Remoxy, Pain Therapeutics Inc. and Durect Corp. both plunged. Durect shares dropped by 89 cents, or 29 %, to $2.20. Pain Therapeutics stock gave up $4.83, or 52%, to $4.41.

Remoxy is similar to Purdue Pharma LP’s pain drug OxyContin. Both drugs contain an extended-release version of the drug oxycodone and both are used to cure severe pain. OxyContin is one of the most frequently abused prescription drugs, and Remoxy is designed to be more difficult to abuse. The oxycodone in Remoxy is in a thick liquid form, which is designed to make it hard to crush and snort, or be injected, or dissolved in alcohol. Remoxy is a key part of Pfizer’s $3.6 billion acquisition of King Pharmaceuticals, which closed in March.

Purdue began selling a new tampering-resistant version of OxyContin last year. The time-release formula in the original version could be avoided if the drug was crushed or dissolved, which delivered the full dose quickly and created a high similar to heroin.

The FDA were concerned about the abuse of prescription pain drugs, and finally in May, the agency called a meeting with drug companies who were studying extended-release opioid pain drugs were matters on the ways to train prescribers and reduce the risks of the drugs were disscused. Pfizer stated such issues to be a complicated approval for Remoxy.

The agency delayed the approval of Remoxy in December 2008, stating it needed more evidence and vital information before it could sanction the approval.

Remoxy was developed by Durect, which licensed it to Pain Therapeutics in 2002. Pain Therapeutics later sublicensed the rights to King Pharmaceuticals, which was acquired by Pfizer.


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