Expert panel to mull broader Fentora use

Fri, 02 May 2008 06:59:55 -0400

Everyone suddenly has an opinion on Fentora. Good opinion: The Cephalon painkiller got European approval a couple of weeks ago, after two years on the market in the U.S. Another good opinion, in the imitation-is-flattery department: Watson Pharmaceuticals filed for the FDA OK on its copycat version of the oral med. In good opinion number three, analysts pooh-poohed Watson's generic challenge, saying, "Fentora is a novel invention and the patents are strong."

Then there's one not-so-sure opinion, from none other than the FDA. As the anesthetic drug advisory committee prepares to discuss broadening usage of Fentora at next week's meeting, an agency staffer raised the twin specters of drug abuse and adverse events in briefing documents. Fentora's current risk-management programs have already failed in a few instances, the documents state, leading to serious adverse events, including overdose deaths. You'll recall that the company strengthened warnings on Fentora's label to help prevent those problems, which seem to stem from prescribing the med inappropriately and from substitution errors.

Given these problems, the documents say, expanding Fentora's indication beyond breakthrough cancer pain could lead to more misuse. And it could make the med more accessible to potential abusers. Key to approval, the staffer wrote, would be an effective risk management program. Is this possible? We'll see what the advisory committee says next week.

- read the FDA briefing
- see the Euro OK piece at Motley Fool
- check out Watson's release
- read the patent coverage in the Chester Daily Local

Pros use pills to boost brainpower

Thu, 10 Apr 2008 06:59:57 -0400

Fuzzy-headed today? Then pop a pill. Professionals of all kinds are doing it these days, according to a survey taken by Nature. Young, old, you name it--they're taking various meds to boost their concentration and memory. Some 62 percent prefer Ritalin, the ADHD med made by Novartis. Another 44 percent liked Cephlon's Provigil, the "keep-awake" drug. Others used Adderall or another amphetamine, beta blockers, even centrophenoxine, a dementia med.

Now, the survey was open only to Nature subscribers, who tend to be scientists, engineers, or folks like journalists who follow science closely. So it's not a generalized, randomized bit of research. (Of the 1,400-odd people who responded, about 15 percent were biologists and 15 percent engineers; 12 percent were educators, 8 percent worked in the medical field, and 7 percent in the media.) But it does show a clear trend.

Another thing: Almost 80 percent of the respondents said healthy people should be allowed to take cognitive-enhancing drugs if they choose. But even more--86 percent--felt that kids under 16 shouldn't be on any of these meds.

- read the Washington Post story
- check out the item in the WSJ Health Blog

Related Articles:
Provigil study sparks debate over ability to enhance alertness
Provigil--Top 10 Warnings and Recalls
Study: Teens abusing prescription drugs
FDA panel wants 'black box' on ADHD drugs