Race for tamper-resistant pills could be worth $1 billion

4/29/2008

STAMFORD, Conn. Purdue Pharma, the manufacturer of the painkiller OxyContin, is leading the race against smaller drug companies that are trying to introduce tamper-resistant pills that addicts can’t abuse, according to Bloomberg.

The drugmaker will ask a joint panel of U.S. advisers next week to back a new OxyContin formula that may prevent abusers from crushing the pill or dissolving it in alcohol to release several hours of narcotics at once. Pain Therapeutics, Alpharma and Elite Pharmaceuticals predict a $1 billion market for alternatives they’re developing even if Purdue beats them to pharmacies.

Purdue has not disclosed how its new OxyContin technology works or how effective it has been in studies. A review of pending patents suggests the pill has “rubbery characteristics” to prevent tampering and may release no more than a quarter of its active ingredient when dissolved in ethanol, said Corey Davis, a Natixis Bleichroeder analyst. The new OxyContin formula may be approved by July, at least six months ahead of any competitors, Davis said.

A taffy-like version of oxycodone, the active ingredient in OxyContin, is being developed by Pain Therapeutics and partner King Pharmaceuticals. The gummy texture of the capsule, Remoxy, is difficult for abusers to convert into a form that can be injected or snorted and resists dissolving in alcohol and water. The companies plan to submit Remoxy this quarter for approval from the Food and Drug Administration.

Alpharma and Elite are counting on the chemical naltrexone, which can counteract most of the euphoria gained from opioids. Their painkillers include naltrexone encased in a protective coating that allows the chemical to pass through the digestive tract unabsorbed when the drug is taken as directed. When the pill is crushed, chewed or cut open, the naltrexone is released along with the narcotic, preventing it from causing a high.

Embeda, an extended-release morphine pill being developed by Alpharma, has a kernel of natrexone at its center. The drugmaker submitted Embeda to the FDA in February and then retracted its request for approval April 21 to revise undisclosed technical issues. Alpharma said it plans to resubmit the application as soon as possible.

ELI-216, a once-a-day capsule made by Elite contains tiny pellets of naltrexone and oxycodone. Elite said it plans to start the final stage of testing ELI-216 in people soon.

King is also testing a painkiller called Acurox that combines oxycodone with the chemical niacin, which causes facial flushing if taken in excess.

Last year, prescription opioids brought in sales of $6.37 billion, according to IMS Health.

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