Vyvanse Approved for Binge Eating Disorder

The U.S. FDA provide approval for the expanded indication for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of moderate to severe binge eating disorder (BED) in adults. Vyvanse, manufactured by Shire, is the first drug approved for BED, which results in patients overeating when not feeling hungry and often eating to the point of being uncomfortably full. The FDA’s approval of Vyvanse for BED was based on two clinical trials that showed that Vyvanse decreased the number of binge days per week compared to a placebo. Vyvanse, a central nervous system stimulant, is already approved as a maintenance treatment in adults and children six years of age and older with attention deficit hyperactivity disorder (ADHD).

The recommended dose for BED should be titrated up to 50mg to 70mg per day. The recommended dose for ADHD should be titrated up to 30mg to 70mg per day. Vyvanse is supplied as 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.