NOC Watch – Abstral, Gelnique

June 2011

Abstral® (fentanyl)

Abstral® is a new sublingual formulation (i.e. dissolving under the tongue) of the potent narcotic pain reliever, fentanyl, a drug which is currently only available as a patch or by injection.  Abstral® is the only narcotic available that disintegrates quickly under the tongue, providing fast and effective treatment of “breakthrough pain” for cancer patients already receiving sustained-release opioids for chronic cancer pain.

Like all narcotics, Abstral® has significant potential for abuse and misuse.  In the US, this product is only available through an FDA mandated program called the Abstral® Risk Evaluation and Mitigation Strategy (REMS) in order to minimize the risk of overuse, abuse, addiction, and diversion.  As of yet, there have not been any such programs mandated for the use of Abstral® in Canada.  Pricing information for this product is not yet available.

Gelnique® (oxybutynin chloride gel)

Gelnique® is a new formulation of an existing oral drug product, oxybutynin chloride, used to assist patients with overactive bladder.  Gelnique® is a clear gel that is rubbed on to the skin to help with symptoms of urgency, frequency, urge incontinence and/or bedwetting.  The gel is applied to different sites including the upper arm, shoulders, thighs or abdomen.  Gelnique® gets absorbed directly into the bloodstream through the skin and has been shown to significantly reduce the number of incontinence episodes associated with overactive bladder per day compared to placebo.  The safety and efficacy of Gelnique® has not been evaluated in children or adolescents less than 18 years.

Since topically-applied oxybutynin is not metabolized in the body the same way as the orally administered product, it is reported to have a lower incidence of dry mouth – the most common side effect among users.  That said, with Canadian pricing for Gelnique® still unavailable, it will be important to compare the cost per day of this new formulation against other treatments currently available for overactive bladder, including generic oxybutynin, in order to evaluate its incremental value for plan sponsors and their members over existing alternatives.

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