What is Nuplazid?
Manufactured and marketed by Acadia Pharmaceuticals, Nuplazid is an atypical antipsychotic drug used to treat hallucinations and delusions caused by Parkinson’s disease psychosis. The medicine works by lessening symptoms such as seeing or hearing things that are not there (hallucinations) and false beliefs (delusions). Nuplazid was classified by the FDA as a “breakthrough therapy,” and expedited to the U.S. market on April 29, 2016.
Nuplazid May Increase Parkinson’s Hallucination Risks: ISMP Report
A report published by the Institutes for Safe Medication Practices (ISMP) in Nov. 2017 warns of potential safety problems associated with Nuplazid and Entresto, a combination drug for use in heart failure developed by Novartis. The researchers found at least 2,236 adverse events associated with Nuplazid during its first year on the market. Of these, 487 events were classified as hallucinations, a symptom of Parkinson’s disease Nuplazid is prescribed to treat.
The researchers concluded that Nuplazid may be ineffective for some patients at treating hallucinations, and may even worsen the problem in some cases. Additionally, the authors suggested that approval of the medicine was expedited due to its classification as a “breakthrough drug,” and that studies have shown that the drug’s risks outweigh any potential benefit.
“It relied on a single clinical trial indicating a minimal treatment effect, used a measurement scale for symptoms that had not been validated, and succeeded only after three previous trials had failed to demonstrate a benefit,” ISMP said in the report. “Further, the agency’s medical reviewer recommended against approval and was overruled. He noted that although other psychiatric drugs were often approved on limited evidence of benefit, in the case of pimavanserin treatment more than doubled the risk of death and/or serious adverse events in its pivotal trial.”
Nuplazid Side Effects
FDA Urged to Require Warning on Parkinson’s Drugs for Compulsive Behaviors
In a petition filed with the FDA in June 2016, the consumer watchdog group Public Citizen said that a review of more than 80 studies called for “black box warnings” on a number of Parkinson’s disease medications, including Requip and Mirapex. A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug. Although Nuplazid was not specifically mentioned in the petition, the drug is in the same category and has a similar mechanism of action as those that were.
FDA Re-Examines Safety of Parkinson’s Drug
What is a Breakthrough Therapy?
A “breakthrough therapy” is a drug that has, according to the FDA, demonstrated “substantial improvement” in patients with serious or life-threatening diseases compared to treatments already on the market. Congress created this designation in 2012 in an effort to streamline the FDA’s approval process, which has been widely criticized as being too slow. Approximately 200 medications have been granted the Breakthrough Therapy designation since its creation.
Securities Class Action Lawsuit
In March 2015, a class action lawsuit was filed against Acadia Pharmaceuticals in the U.S. District Court for the Southern District of California on behalf of purchasers of the company’s publicly traded securities. The complaint alleges that from February 26, 2015, to March 11, 2015, Acadia made false and misleading statements, and/or failed to disclose facts regarding its timing of submitting Nuplazid for a New Drug Application (“NDA”) to the FDA. As a result of the company’s false and misleading statements in this regard, Acadia securities traded at artificially inflated prices, with its stock trading at prices above $45 per share, according to the lawsuit.
Can I Participate in a Class Action?
Although we are a nationally-recognized class action firm, the Pharmaceutical Litigation Group at Schmidt & Clark, LLP, has decided against the filing of such a claim in the Nuplazid litigation, and is only filing individual claims on behalf of people who had severe injuries. Our lawyers decided on this course of action because individual suits tend to pay off much better for plaintiffs in these types of cases, and each client has a much greater degree of control over his/her own case. Contact us today to learn more about your legal rights.
Do I Have a Nuplazid Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Nuplazid lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you have been harmed by the side effects of Nuplazid, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.