The FDA has gone so far overboard in its quest for absolute drug safety that it becomes ensnared in its own circular logic. Consider Alpharma’s Embeda, an abuse-resistant formulation of morphine that went before an advisory panel on Friday. The FDA argued to the panel that Embeda’s abuse-resistant features might make docs less likely to interrogate patients to ascertain their potential for abuse!! If this is not a Catch-22 then I do not know what is!
WASHINGTON, Nov 14 (Reuters) - Alpharma Inc's (ALO) experimental morphine-based painkiller is somewhat less attractive to drug abusers, a U.S. advisory panel said on Friday, and the company's shares rose nearly 14 percent.
Alpharma is seeking U.S. Food and Drug Administration approval to market its drug ALO-01 to chronic pain patients which aims to deter abuse with an ingredient to curb the drug's euphoric effects when its capsule is crushed or chewed.
"I think there is some incremental benefit" for thwarting abuse, said panel chairman Dr. Jeffrey Kirsch, head of anesthesiology at Oregon Health & Science University, echoing most panelists' cautious views.
The FDA will make the final decision. It is also weighing a similar product from King Pharmaceuticals Inc (KG), which is seeking to buy Alpharma.
ALO-01, which Alpharma hopes to sell under the trade name Embeda, contains long-acting morphine to provide pain relief for 12 to 24 hours. It also has an inner core of naltrexone, a drug used to treat drug and alcohol withdrawal that reverses morphine's effect.
Alpharma said studies showed the core was activated when the capsule is crushed, a method used by drug abusers looking for a quick high, but had little effect when taken normally.
Such formulation would deter a number of abusers, but not all, said Joseph Stauffer, the company's chief medical officer.
"We believe this medication provides those roadblocks... Nevertheless, nothing is perfect," he told the panel.
Caris & Company analyst David Moskowitz said Friday's panel findings were likely to help fuel King's takeover. "That just made Alpharma that much more attractive," he told Reuters.
Alpharma shares rose nearly 14 percent to close at $34.75, while King shares fell 1.1 percent to close at $9.64. Both trade on the New York Stock Exchange.
Several panelists said intent abusers will still find a way to work around the Alpharma drug's design barriers.
Sales of long-acting morphine drugs have soared in recent years, accounting for 4.2 million prescriptions in 2007, up from about 1 million in 1998, according to the FDA.
While most are for legitimate use, such painkillers are increasingly sought after because prescription drugs can be more easily obtained than illegal ones through theft, false prescriptions or lax physicians.
At the meeting, FDA staff said it was unclear from the company's data whether enough naltrexone would be absorbed in certain situations, such as when ALO-01 was chewed or snorted. They also questioned whether doctors would be less stringent in screening for potential abusers because they think ALO-01 cannot be mishandled.[LOL, you can’t win with the FDA—it’s a Catch-22!]
Panelists echoed such concerns, though many said the formulation was an improvement over currently available drugs.
Numerous patient and law enforcement groups urged approval, saying the drug could help deter addicts while still providing relief to those experiencing chronic pain.
But panelist Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said more focus should be placed on monitoring prescribing and patient use of such drugs. "I think people are overestimating the magic of the novel formulation."
Rival morphine painkillers include privately held Purdue Pharma's MS Contin and King's Avinza, as well as Alpharma's Kadian, which could face generic competition as soon as 2010.
Kadian brought in $167.7 million in 2007 sales, about 23 percent of the drugmaker's total revenue.
On Thursday, the same FDA panel said King's drug -- a gel capsule made with Pain Therapeutics Inc (PTIE) called Remoxy -- appeared less susceptible to abuse than other similar drugs such as Purdue Pharma's widely used Oxycontin.‹
News 
Market Data 
Discover 
AI
