Lorcaserin (Lorqess) leaving the FDA launching pad?

May be smooth sailing if you are looking to Lorquess and losing that weight

Lorcaserin (APD-356 and probably branded as Lorqess) will be reviewed by the FDA on Thursday, September 16th. I’ll be there once again, just like I was for the Qnexa review.

IF you remember, Qnexa (phentermine and topiramate) was recommended for rejection by the same committee—yet I think lorcaserin is different. It’s about the safety profile. The target is serotonin and those of you who remember fen-phen, might recall that that pair hit the same compound and lead to heart valve problems. What’s different? Lorcaserin IS SPECIFIC to the 5-HT 2C receptor. Heart valvue problems are associated with the 5-HT 2B receptor. While this is a complicated system, the interesting part is that the company (Arena Pharmaceuticals) has two studies (BLOSSOM and BLOOM) which point to clear safety advantages!

BLOSSOM (Behavioral Modification and Lorcaserin Second Study for Obesity Management) showed that this drug left the heart valves alone and even spared heart valves in some patients with mild abnormal blood return (regurgitation) in the mitral or aorta. BLOOM was a study of 3,182 obese or overweight people who ALSO had diabetes, high blood pressure, heart and blood vessel disease (cardiovascular), sleep apnea or impaired sugar (glucose) tolerance. These patients either got medicine or a sugar pill (placebo) for a year, THEN were randomly changed (reassigned) 2:1 to either get a sugar pill or the medicine for another year.

Importantly, this company worked echocardiograms into the study design to look for a 20% increase in valve problems. In the BLOOM study at 104 weeks, sugar pill (placebo) showed a 2.6% rate of heart valve problems, while lorcaserin 10 mg twice a day had a 2.7% rate. No significant difference. In BLOSSOM, after a year (week 52)—placebo was 2.0% and lorcaserin 10 mg twice a day was 1.3%...yes, it was less than placebo.  While no one can predict an FDA panel recommendations, I’ve reviewed the studies and think that lorcaserin has a very very strong chance for recommendation for approval!

All the best,

Dr. Jim.

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