ImageWatson Pharmaceuticals's Gelnique is the first gel to be approved by the FDA for the treatment of overactive bladder, and provides an advantageous side-effect profile over current oral anticholinergic and patch treatments. As a result, Datamonitor expects Gelnique to be beneficial for a niche population and to generate $124m in 2016.

Watson Pharmaceuticals has announced that Gelnique, a topical gel containing 10% oxybutynin chloride, has been approved by the FDA for the treatment of overactive bladder (OAB) with the symptoms of urge urinary incontinence. Gelnique is a transdermal gel reformulation, which delivers the anticholinergic oxybutynin – a well known and highly genericized oral drug with proven efficacy – in a manner that achieves therapeutic blood levels of the active compound over 24 hours after a single, daily application. Gelnique is the first gel to be approved by the FDA for the treatment of OAB and the second topical treatment after Oxytrol, a patch formulation of oxybutynin also developed by Watson which enjoyed limited commercial success.

While the current market is dominated by oral anticholinergic therapies, Datamonitor believes that oxybutynin gel can provide a beneficial alternative to patients. Oxybutynin gel is not metabolized by the liver in the same way as oral oxybutynin, resulting in a low level of side effects such as dry mouth and constipation.

An additional advantage is that the gel will not have to compete directly with the oral agents and can also be marketed as an add-on therapy. From a patient perspective, Gelnique may be perceived to be more cosmetically appealing than patches and could result in less irritation and skin rashes. As a result, Gelnique is likely to be beneficial for a niche patient population and Datamonitor expects the gel to take market share from Oxytrol, as well as from the oral anticholinergics.

By 2016, Datamonitor estimates that the oxybutynin gel market will be worth $198m across the US, France, Germany, Italy, Spain and the UK, accounting for 92% of the topical market and 12% of the total cholinergic market. While Watson's product is likely to face competition from Antares Pharma's Anturol, an oxybutynin transdermal gel currently in Phase III development for OAB, Datamonitor expects that Gelnique will take a greater share of the gel market. Watson will not only benefit from its first-to-market position, but also from its extensive knowledge of this disease area through marketing Oxytrol. As a result, Datamonitor expects Gelnique sales to account for 63% of the oxybutynin gel market, generating $124m in 2016.