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Shire Files NDA for Chewable Version of ADHD Drug Vyvanse

Shire plc SHPG announced that it submitted a New Drug Application (NDA) to the FDA for an alternate formulation of Vyvanse as a chewable tablet.

Shire believes that the chewable tablet will be easy to consume for patients who may have difficulty in swallowing or opening a capsule.

We note that Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged six and above, and for the treatment of moderate-to-severe binge eating disorder (B.E.D.) in adults.

Shire also stated that the proposed indications for Vyvanse chewable tablets remain unchanged from the currently approved indications for the capsule formulation.

Shire holds a strong position in the ADHD market, with Vyvanse as the growth engine of the company. The drug accounted for approximately 28.2% of the company’s total product sales in 2015. We are also encouraged by Shire’s efforts on a label expansion of Vyvanse.

Last week, Shire announced positive top-line results from a phase III trial on its ADHD candidate, SHP465. The four-week phase, randomized, double-blind, multi-center, placebo-controlled study evaluated the safety and efficacy of SHP465 in children and adolescents aged 6–17 years suffering from ADHD. Data from the study showed that SHP465 met the primary endpoint as it showed improvement in ADHD symptoms in children and adolescents. SHP465, administered as a daily morning dose, was superior to placebo on the change from baseline in the ADHD-RS-IV (ADHD rating scale) total score. The study also met its secondary endpoint.

Approval of new drugs and label expansion of existing drugs will further boost Shire’s ADHD franchise.

Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Novo Nordisk A/S NVO, Eli Lilly and Company LLY and Johnson & Johnson JNJ. All the three stocks carry a Zacks Rank #2 (Buy).

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SHIRE PLC-ADR (SHPG): Free Stock Analysis Report
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