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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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May 10, 2012

Arena and Lorcaserin, Back at the FDA

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Posted by Derek

For those of you following Arena Pharmaceuticals and their long-running efforts to get lorcaserin approved by the FDA, there's a committee hearing on that matter today. Adam Feuerstein is live-blogging the event here. The big issues, now with fresh data: tumors in rat models, and possible heart-valve damage, versus efficacy. The FDA has until June 27 to make a decision.

Comments (10) + TrackBacks (0) | Category: Diabetes and Obesity


1. Watson on May 10, 2012 11:50 AM writes...

It seems Arena is trying to sidestep some of the efficacy:risk concerns by recommending a special protocol to guide doctors in identifying "responders" at an early stage of therapy.

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2. Anonymous on May 10, 2012 2:14 PM writes...

so far, the consensus is 'pass'

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3. Watson on May 10, 2012 3:06 PM writes...

Pass it is. I'm starting a pool on how long it will be before the litigious groups starts ads decrying CV associated with lorcaserin at all hours of the day.

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4. Anonymous on May 10, 2012 3:08 PM writes...

18 yes and 4 no

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5. Philip on May 10, 2012 10:42 PM writes...

@1, Yes a really special protocol, if it does not work for you, than quit taking it. As for efficacy, it meet the FDA guideline. It did not exceed the guideline by much, but that is not the point. The guideline was set so that significant weight loss occurred in a significant percent of the patients.

@3, The CV stuff is going to take years to figure out. It looks like just losing weight can cause heart valve problems. How much if any lorcaserin adds to that is not an easy nut to crack. Not that that would keep the sharks away.

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6. Morten G on May 11, 2012 8:18 AM writes...

So what's the state of the art in obesity drugs these days?
Okay Wikipedia tells me that it's:
Orlistat, lipase inhibitor
Acarbose, alpha glucosidase
Byetta, GLP-1 analogue
Victoza, GLP-1 analogue
Pramlintide, amylin analogue

So basically peptide analogues of the glucose regulatory system and macronutrient uptake inhibitors.

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7. Anonymous on May 11, 2012 4:12 PM writes...

@6, it's Vivus' Qnexa (topiramate/phentermine), Orexigen's Contrave (buproprion/naltrexone), and Arena's Lorquess (lorcaserin).

Reading between the lines on Contrave made me wonder if the method of action was "If you feel happier, you might cut back on the beer!"

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8. Philip on May 12, 2012 5:10 PM writes...

@6 and @7: Please keep in mind I am a computer geek, not a chemist or pharmacist.

A little more general, the state of the art looks to be a serotonin 5-HT3c receptor antagonist (lorcaserin, topiramate, naltrexone or fenfluramine) and an amphetamine (phentermine or buproprion).

The problem is you do not want to hit the 5-HT3b receptor (like fenfluramine does) that causes heart valve problems. I am not to sure if a small effect on the 5-HT3a receptor is a bad deal. Feel good while losing weight?

It looks to me like the amphetamine helps you get rid of the weight, and the 5-HT3c antagonist helps you feel like you are not hungry. A powerful combination. I think that is why the combination drugs produce a lot more weight loss than a single drug like lorcaserin. My guess is that lorcaserin will be LorcPhen off label ASAP and as a combination drug soon (Arena has a patent).

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9. Philip on May 13, 2012 7:30 PM writes...

Sorry, 5-HT2, not 5-HT3.

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10. Morten G on May 14, 2012 4:58 AM writes...

@7 Anonymous and @8 Philip:

None of those are approved yet...
I have more faith in the combinations of approved things than Arena's though. In general I'm sceptical of the neurotransmitter interference strategy for obesity.

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