Expanded Indication for Vraylar
November 13, 2017 – The U.S. FDA has approved an expanded indication for Vraylar™ (cariprazine), manufactured by Allergan, as a maintenance treatment for adults with schizophrenia. The drug has been previously approved for the treatment of acute schizophrenia and acute manic or mixed bipolar I disorder episodes.
Maintenance therapy plays an important role in maintaining the health of patients with schizophrenia. An estimated 80% of the 2.4 million Americans diagnosed with schizophrenia relapse within two years without effective maintenance therapy. The disease itself can be a challenge to treat, and individual responses to different treatment regimens vary. Patients who received Vraylar as part of a clinical trial were less likely to relapse than those who were given a placebo.
Recommended dosing for Vraylar can range from 3mg to 6mg once daily. It is available in 1.5mg, 3mg, 4.5mg, and 6mg capsules. A black box warning cautions that Vraylar should not be used in elderly patients with dementia, as it may increase the risk of death.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.