— 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. —
WALTHAM, Mass.--(BUSINESS WIRE)--Nov. 9, 2017--
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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Source: Alkermes plc
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