An investigational pilot study evaluating co-administration of diet drug Belviq (Lorcaserin) and appetite suppressant Phentermine Hcl has met the primary safety objective after 12 weeks of treatment.
The trial results demonstrated that the short-term combination of Belviq and Phentermine Hcl does not appear to be associated with an exacerbation (worsening) in the proportion of pre-specified adverse events compared to therapy with Belviq alone.
Belviq was approved by FDA as an addition to a reduced-calorie diet and exercise for chronic weight management in June of 2012.
Eisai Co., Ltd. markets and distributes Belviq in the United States, and Arena Pharmaceuticals Inc. (ARNA) manufactures and supplies the finished commercial product from its facility in Switzerland.
Phentermine Hcl is available under brand names like Adipex-P, Ionamin, Duromine and also as generic versions.
Remember the diet-pill cocktails, Fen-Phen, a combination of Fenfluramine and Phentermine, and Dexfen-Phen, a combination of Dexfenfluramine and Phentermine, which were popular in the 1990s?
Though Fenfluramine, Dexfenfluramine and Phentermine were all approved by the FDA, the Fen-Phen and Dexfen-Phen cocktails were never approved but were used off-label. However, no studies were presented to the FDA to demonstrate either the effectiveness or safety of Fen-Phen and Dexfen-Phen.
In 1997, there were increasing reports of patients developing heart valve disease after taking Fen-Phen, Fenfluramine or Dexfenfluramine that prompted the FDA to withdraw Fenfluramine and Dexfenfluramine from the market.
Commenting on the pilot study results of co-administration of Belviq and Phentermine, Gary Palmer, MD, Eisai's Chief Medical Officer said, "The results of this investigational study provide us with additional safety data that enhance the body of knowledge we have for Lorcaserin."
ARNA closed Tuesday's trading 3.82% higher at $4.35. In after-hours, the stock gained another 2.99% to $4.48.
For comments and feedback: editorial@rttnews.com