Business View Magazine - June 2016 19
son’s cheek until it dissolved. While effective, a pill
or film may be lost, forgotten or stolen. However, as
an implant, Probuphine provides a new treatment
option for people in recovery who may value the
unique benefits of a six-month implant compared to
other forms of buprenorphine, such as the possibility
of improved patient convenience from not needing
to take medication on a daily basis. An independent
FDA advisory committee supported the approval of
Probuphine in a meeting held earlier this year.
“Opioid abuse and addiction have taken a devastat-
ing toll on American families. We must do every-
thing we can to make new, innovative treatment op-
tions available that
can help patients
regain control over
their lives,” said
FDA Commission-
er Robert M. Califf,
M.D. “The FDA’s
approval provides
the first-ever im-
plantable option to
support patients’
efforts to maintain
treatment as part
of their overall re-
covery program.”
Expanding the use and availability of medication-as-
sisted treatment (MAT) options like buprenorphine
is an important component of the FDA’s opioid ac-
tion plan and one of three top priorities for the U.S.
Department of Health and Human Services’ Opioid
Initiative aimed at reducing prescription opioid and
heroin related overdose, death and dependence.
Opioid dependence is the diagnostic term used for
the more common concept, “addiction,” in the Pro-
buphine clinical trials. Addiction is defined as a clus-
ter of behavioral, cognitive, and physiological phe-
nomena that may include a strong desire to take the
drug, difficulties in controlling drug use, persisting
in drug use despite harmful consequences, a high-
er priority given to drug use than to other activities
and obligations, as well as the possibility of the de-
velopment of tolerance or development of physical
dependence. Physical dependence is not the same
as addiction. Newer diagnostic terminology uses
the term “opioid use disorder,” which includes both
milder forms of problematic opioid use as well as
addiction.
MAT is a comprehensive approach that combines
approved medications (currently, methadone, bu-
prenorphine or naltrexone) with counseling and oth-
er behavioral therapies to treat patients with opioid
use disorder. Regular adherence to MAT with bu-
prenorphine reduces opioid withdrawal symptoms
and the desire to use, without causing the cycle of
highs and lows associated with opioid misuse or
abuse. At sufficient doses, it also decreases the
pleasurable effects of other opioids, making contin-
ued opioid abuse less attractive. According to the
Substance Abuse and Mental Health Services Ad-
