Alkermes Calls for Impartial National Review of Scientific Data Supporting the Use of FDA-Approved Treatment Options for Opio...
November 09 2017 - 08:00AM
Business Wire
— Treatment System is Inadequate and Must
Evolve to Meet the Needs of Patients and the Community. Decisions
Should be Based on Unbiased Assessment of all Existing Data. —
Amid one of the nation’s deadliest and most significant public
health crises of our time, Alkermes is calling for a formal review
by the National Institutes of Health (NIH) of data related to all
FDA-approved medication-assisted treatment (MAT) options for opioid
dependence. 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.
“In the face of this epidemic, the country would benefit from a
comprehensive review of the three FDA-approved treatment options by
an impartial scientific organization, such as NIH and the National
Institute on Drug Abuse (NIDA). It is time to advance the
discussion, and reject inaccurate and dangerous assertions
regarding the quality and extent of data for current FDA-approved
medicines,” said Elliot Ehrich, M.D., Executive Vice President,
Research and Development of Alkermes. “Each of these medicines has
an important role to play in our national response to this
epidemic.”
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 (CDC), the U.S. Food and
Drug Administration (FDA), the Surgeon General, and the National
Institute of Corrections (NIC), and unbiased and unconflicted
data-driven patient and professional associations, including the
American Academy of Addiction Psychiatry (AAAP). 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.
“As a nation and treatment community, we need to modernize our
treatment system to provide patient-centered, data-driven care.
Alkermes has been on the front lines of this epidemic for many
years working to change the status quo and to address this national
emergency,” said Richard Pops, Chief Executive Officer of Alkermes.
“We will continue our tireless drive to effect positive change for
the benefit of patients, their families and the community, and will
not allow unsubstantiated comments that impugn the validity of our
medicine and integrity of our company to hinder our progress. A
comprehensive, NIH-led review of the treatment paradigm would
provide an appropriate national platform to elevate this
conversation and meaningfully advance our nation’s response to this
epidemic.”
About Opioid Dependence
A chronic brain disease, opioid dependence is characterized by
cognitive, behavioral and physiological symptoms in which an
individual continues to use opioids despite significant harm to
oneself and others.1 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 U.S. According to the 2016 U.S. National Survey on
Drug Use and Health, nearly 2 million people aged 18 or older had
an opioid use disorder.2
About Alkermes
Alkermes plc is a fully integrated, global
biopharmaceutical company developing innovative medicines for the
treatment of central nervous system (CNS) 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. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and
manufacturing facility in Athlone, Ireland; and a manufacturing
facility in Wilmington, Ohio. For more information, please visit
Alkermes’ website at www.alkermes.com.
1 DSM-IV-TR, American Psychiatric Association.
2 SAMHSA. Behavioral Health Trends in the United States: Results
from the 2016 National Survey on Drug Use and Health.
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