Labeling Update for Rexulti
September 23, 2016 - The U.S. FDA approved Rexulti® (brexpiprazole) to include the results from a clinical trial in its prescribing information and labeling can now include information about its use as schizophrenia maintenance therapy. The FDA approved Rexulti in July 2015 as a single therapy to treat schizophrenia and as add-on treatment for major depression. The continuation of a previous trial found that patients with schizophrenia who were stabilized on Rexulti and kept taking it had longer times to relapse than study patients who were switched to an inactive placebo. Rexulti is an atypical antipsychotic that is believed to work by partially activating both dopamine and serotonin receptors to help regulate neurotransmitter levels. A boxed warning cautions that Rexulti should not be used by elderly patients with psychosis due to dementia and that patients younger than 24 years of age should be watched for behavioral changes while they take it. Rexulti was developed jointly by H. Lundbeck A/S and Otsuka Pharmaceutical Company.
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 regular mail or by fax.
- 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 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.