Prior to the FDA’s approval yesterday of Vivus’ Qsymia (formerly Qnexa) and last month (June 2012) of Arena Pharmaceuticals’ Belviq (Lorcaserin), it had been 13 years since the FDA had approved a drug for the treatment of obesity when, in 1999, the FDA approved GlaxoSmithKline’s Xenical (Orlistat).
Qsymia, unlike Belviq, is a “combination” drug in that it is a combination of phentermine, an anorectic (i.e., appetite suppressant) and an anticonvulsant (Belviq is single drug that targets appetite suppression as a serotonin-receptor agonist).
In the intervening years between approval of Xenical and Lorcaserin, the prevalence, drug/device industry focus and market (along with hype) for obesity treatment has grown dramatically. This lull between drug approvals has not been without a clinical or industry response, however, as gastric bypass procedures (roux en-y and others) and medical device-driven sales promptly responded to address the issue, with a variety of obesity device treatments spanning restrictive devices, artificial fullness devices, malabsorption devices, gastric emptying devices and appetite suppression devices being launched or nearing launch. Key device manufacturers include Allergan, Ethicon Endo-Surgery, Helioscopie, AMI GmbH, Bariatric Solutions GmbH, Cousin Biotech, MID, and others.
But the market for obesity has nonetheless been left wanting for more effective drugs. The removal of Fen-Phen from the market, the prior FDA rejection of Lorcaserin, Qnexa and Contrave (Orexigen Therapeutics), and a seemingly bogged down regulatory process in general, in the face of growing popular press and clinical research regarding the enormous obesity problem, have all served to act as a potential slingshot for the launch of new obesity drugs.
Yet, despite the approval of Lorcaserin and now Qsymia, there remain big challenges for the obesity drug market, with the FDA’s requirement for post market surveillance on both Lorcaserin and Qsymia, the obvious impact (sales, stock price) being felt by Arena on Vivus’ one-upsmanship with a potentially more effective drug and continued competition from stubbornly effective medical devices that, however inelegant at times, simply get the obesity management job done.
Qsymia, like Fen-Phen, is a combination of two drugs, but unlike Fen-Phen, which was a combination of fenfluramine and phentermine, Qsymia is a combination of phentermine and topiramate. (It was in fact the ingredient fenfluramine that was responsible for the recall of Fen-Phen, while phentermine continues to be considered a safe ingredient.)
Thus far, the impact of Qsymia’s approval is financial rather than clinical, as Vivus’ stock has gained at the expense of Arena’s, since Qsymia is considered a more effective option in obesity management than is Arena’s Belviq. Initial market introduction, expected later this year, will further determine the relative success of Arena/Belviq and Vivus/Qsymia.
Next on the obesity drug horizon is Contrave from Orexigen Therapeutics. Like Belviq and Qsymia, Contrave received the FDA thumbs down, driving its manufacturer to produce more clinical data on safety for resubmission, which now appears ahead of schedule, but still likely not to result in an FDA approval before the end of 2013. Contrave is a combination drug comprised of bupropion (an antidepressant) and naltrexone (an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence).
The market for the expanding array of obesity treatments is expected to become considerably more fragmented as new drug and device options hit the market. Given the cost/benefit of alternative treatments, MedMarket Diligence projects that, in the mid-term at least, combination drugs like Belviq, Qsymia and Contrave (when ultimately approved) will begin to command the largest share of the market. (See the graphica illustrating the projected outlook for obesity drug and device treatments, from 2011 to 2019, in the Americas, Europe and Asia/Pacific.)
MedMarket Diligence has tracked and continues to project the outlook for both drug and device-based obesity treatments in Report #S835, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019”.