Avenacy Announces Launch of Prochlorperazine Edisylate Injection, USP in the U.S. Market

2024-06-26

上市批准临床结果

Represents the Company’s eleventh product launch since inception in October 2023 SCHAUMBURG, Ill.--(BUSINESS WIRE)-- Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Prochlorperazine Edisylate Injection, USP in the United States as a therapeutic generic equivalent for COMPAZINE® as approved by the U.S. Food and Drug Administration. Prochlorperazine Edisylate Injection, USP is indicated to control severe nausea and vomiting and for the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. This press release features multimedia. View the full release here: (Photo: Business Wire) Avenacy's Prochlorperazine Edisylate Injection, USP is available in 10 mg/2 mL (5 mg per mL) 10-pack multi-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Prochlorperazine Edisylate Injection, USP will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Prochlorperazine Edisylate Injection, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards. Prochlorperazine Edisylate Injection, USP had U.S. sales of approximately $15 million for the twelve months ending in June 2023.1 Warning Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine Edisylate Injection, USP is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). Please see link for Full Prescribing Information including the Boxed Warning. COMPAZINE® is a registered trademark of GlaxoSmithKline. 1Source: IQVIA About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit .

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