Jan 22, 2010 (Datamonitor via COMTEX) -- Following a regulatory recommendation, Abbott Laboratories appears to have suspended sales of its controversial obesity drug Reductil in Europe. Meanwhile, in the US, the FDA has called for new contraindications to be added to Reductil's label following data from the 10,000-patient SCOUT trial. These issues highlight the many commercial risks inherent in targeting the burgeoning obesity market.

Reductil (sibutramine) is by no means the only marketed obesity product to have fallen foul of safety concerns. The 12 products licensed for medicinal use since the 1930s have yielded numerous restrictions on usage and public health advisories, two discontinuations and six withdrawals prompted by side effects. These have been wide ranging, including neuropathy and cataracts (dinitrophenol), addiction, central nervous system and cardiac toxicity (amphetamines), sudden death (so-called 'rainbow' combination pills, digitalis and diuretics), pulmonary arterial hypertension (aminorex) and cardiac valvulopathy (dexfenfluramine). Most recently, rimonabant (Acomplia; Sanofi-Aventis) faced European withdrawal following European Commission concerns over psychiatric side effects.

From Abbott's perspective, a European withdrawal will represent a major blow. Reductil sales across the five major European markets (France, Germany, Italy, Spain and the UK) account for over 60% of seven major market (US, Japan and the five major European markets) sales, versus an average of 43% over the entire obesity drug sector. Meanwhile, the anticipated FDA contraindications (including use in patients with coronary artery disease, stroke or transient ischemic attack, heart arrythmias, congestive heart failure, peripheral heart disease or uncontrolled hypertension) potentially rule out use in the majority of the otherwise eligible obese patient population.

However, a secondary impact is likely to ripple through the financial markets. The bluff talk of obesity market potential has stimulated interest in widely publicized would-be new market entrants including Orexigen's Contrave (bupropion and naltrexone), Vivus' Qnexa (phentermine and topiramate) and Arena's lorcaserin.

The Reductil rulings in both Europe and the US indicate that while obesity clearly curtails life expectancy and represents a burgeoning economic burden, safety is paramount for any product directed at such a numerous patient population. This is especially pertinent when diet and exercise are effective solutions for the majority of patients, and surgery may be more effective in the long term for the most severely obese patient groups.

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