Therapy Areas: Central Nervous System
Alkermes Calls for Impartial National Review of Scientific Data Supporting the Use of FDA-Approved Treatment Options for Opioid Dependence
10 November 2017 - - Irish biopharmaceutical company Alkermes is calling for a formal review by the US National Institutes of Health of data related to all FDA-approved medication-assisted treatment options for opioid dependence, the company said.

The goal of this review should be to establish a shared national understanding of the characteristics of these medicines and the scientific and medical evidence supporting their use.

This review should evaluate the efficacy and safety of these treatment options, the specific patient populations most likely to benefit from them, as well as the data relating to overdose prevention, diversion, illicit use, craving, patient satisfaction and other important aspects of recovery.

With a complete understanding of the body of evidence supporting MAT, treatment providers in the community will be better equipped to make data-driven treatment decisions customized to individual patient needs.

Alkermes proposes a public meeting, led by NIH/NIDA, which includes presentation and review of medical and scientific data pertaining to FDA-approved medications for opioid dependence, including expert testimony from representatives of NIH, NIDA, the Centers for Disease Control and Prevention, the US Food and Drug Administration, the Surgeon General, and the National Institute of Corrections, and unbiased and unconflicted data-driven patient and professional associations, including the American Academy of Addiction Psychiatry.

There are abundant data on these medicines, and despite this, myths and misperceptions are perpetuated and, as a result, most patients are not gaining access to MAT.

A chronic brain disease, opioid dependence is characterized by cognitive, behavioural and physiological symptoms in which an individual continues to use opioids despite significant harm to oneself and others.

The use of heroin, an illegal opioid drug, and the non-medical use of FDA-approved opioid analgesics, including prescription pain relievers, represents a growing public health problem in the US.

According to the 2016 US National Survey on Drug Use and Health, nearly 2 m people aged 18 or older had an opioid use disorder.

Alkermes is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system diseases.

The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis.
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