ADHD Pharmaceuticals to Branch Out - Repositioning and Remarketing Trumps Research

Tuesday 11 June 2013, Amsterdam

While high disease prevalence encourages pharmaceutical companies to enter into the ADHD market, a lack of understanding surrounding the condition makes drug development problematic.

A new report states that, as multiple ADHD drugs such as Adderall XR (amphetamine and dextroamphetamine), Daytrana (methylphenidate), Intuniv, Concerta (methylphenidate), Strattera (atomoxetine) and Kapvay are set to lose their patents, new treatment options are required to prevent declining market revenue. However, uncertain disease epidemiology is making development difficult.

The ADHD pipeline features some promising molecules, but many are still in early stages of development. The pathophysiology of ADHD is not well understood, as scientific research has struggled to provide any definitive genetic neurological, psychological or environmental causes. The overlap between the mechanisms of action found in
different phases of the pipeline could be due to multiple pharma companies chasing the same recent discoveries, and until the disease mechanism has been established, this competition seems likely to continue.

Treatments which lack the significant side effects of existing treatments would do very well in the ADHD market. All existing therapeutics hold a range of significant negative side effects, including fatigue, nausea, weight loss, insomnia, and even tics. Stimulant therapeutics also hold the potential for abuse, performance enhancement and
even recreational purposes, leading to their classification as Schedule II controlled substances in the US and as controlled narcotics in Japan. Adderall and Strattera even carry black box warnings from the FDA due to the risks associated with their use.

The approval of ADHD drugs across various regional markets could help the therapeutics market. Certain medications are already approved in the US, but not in Europe and Japan, and their use across all geographic regions could greatly improve their revenues. Vyvanse (lisdexamfetamine dimesylate) is a longer lasting, harder to
abuse form of dextroamphetamine, which is the active ingredient in Adderall, and its launch in major European markets in early 2013 is expected to lead to wide adoption across the continent, buoying the region’s ADHD therapeutics market.

Drug repositioning also examines the best way to use existing products. Approved pharmaceuticals already have valuable clinical data on toxicity, safety, and dosing, reducing the time, risk and costs involved in drug development, and various products already marketed for other indications are currently being considered for ADHD, including medications for vertigo, alcohol withdrawal, and other CNS disorders. In the current economic climate, payers will often opt for the cheapest therapeutic option rather than the most efficient therapeutic, and so companies could benefit handsomely by attributing pre-existing and modestly priced medications to treat ADHD.