Nuplazid Receives Approval for New Strength and Dosage Form
June 29, 2018 – The U.S. FDA has approved a new strength and dosage form for Nuplazid® (pimavanserin), manufactured by Acadia Pharmaceuticals.
The new strength, 10mg tablets, allows for simpler dose adjustments for patients who may be taking other medications, such as strong CYP3A4 inhibitors, that can affect how Nuplazid works. Previously, Nuplazid was only available in 17mg tablets.
The new dosage form, 34mg capsules, will provide patients who take the standard recommended dose of 34mg daily a single-pill option for treatment.
Nuplazid is an atypical antipsychotic indicated to treat hallucinations and delusions associated with Parkinson’s disease psychosis. It first received FDA approval in 2016. According to the product’s black box warning, elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death, and Nuplazid should not be used to treat dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
Acadia has launched the new strength and dosage forms. Both the Nuplazid 10mg tablets and 34mg capsules are available at an average wholesale price (AWP) of $3,330.60 per month.
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.