Avenacy Announces Launch of Prochlorperazine Edisylate Injection, USP in the U.S. Market
26 Junio 2024 - 7:00AM
Business Wire
Represents the Company’s eleventh product
launch since inception in October 2023
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.
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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 http://www.avenacy.com/.
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