PHARMACY

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

BY Drew Buono

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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PHARMACY

Anderson highlights NACDS achievements in annual speech

BY Drew Buono

PALM BEACH, Fla. The National Association of Chain Drug Stores president and chief executive officer Steve Anderson addressed the attendees yesterday at the association’s annual meeting with his “State of the Association” speech.

“I think the stakes are very high and we are ready to live and to thrive in this moment,” said Anderson. “In January 2009, we are going to have a new president in the White House, and a new administration that will be serving that president. We are going to have a new congress, new governors and state legislators, and the healthcare debate is going to rage and the response to economic conditions are going to dominate.”

Anderson highlighted some of the policy victories of the association over the past year. This includes a six-month delay of the tamper-resistant paper requirement for Medicaid prescriptions, the two-year delay of California’s e-pedigree requirement, the preservation of access to retail pharmacy for military families and veterans through the TRICARE program and the temporary injunction won by NACDS and the National Community Pharmacists Association to block the Medicaid pharmacy reimbursement cuts that would have gone into effect in January 2008.

“NACDS talked about the cost when patients don’t take their medications as prescribed—by one estimate, $177 billion annually,” said Anderson. “We talked about the seven most common chronic diseases. We cited there a $1.3 trillion annual drag on the economy, not to mention the human suffering. … We talked about the ability of retail pharmacy to make a difference if we are only given the chance.”

Anderson also talked about strengthening the presence of the pharmacy in the health care system. He called for the industry to take action, at this “defining age” in health care. Anderson said, “We have a vision for the future. We are branding pharmacies as the face of neighborhood healthcare.”

“The state of your association is very strong, in large part, because our staff team is working very well together,” said Anderson, who noted that results on issues are the best indicator of strength. “… No silos, no egos—that is way this is supposed to work.”

He also made reference to the economic impact that retail stores have on the economy. “Based on our analysis, retail stores with pharmacies have a total annual economic impact of $2.2 trillion,” said Anderson. This was after he noted that the stores had annual sales of $758 billion, so therefore the effect is almost tripled by pharmacies. For every $1 spent in these stores has a ripple effect of $2.93 throughout the entire economy.

“We do all those things that drive our nation’s economy and produces millions of jobs in this country,” said Anderson. “This is what you do and I think that is pretty amazing.”

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Mylan’s Digitek recalled by Actavis

BY Drew Buono

WASHINGTON Actavis Totowa has notified health care professionals of a Class I nationwide recall of all strengths of Mylan Pharmaceuticals’ drug Digitek.

The drug is used to treat heart failure and abnormal heart rhythms.

The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.

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