BVM June 2016 - page 21

Business View Magazine - June 2016 21
of treatment. The FDA is requiring postmarketing
studies to establish the safety and feasibility of plac-
ing the Probuphine implants for additional courses
of treatment.
The safety and efficacy of Probuphine were dem-
onstrated in a randomized clinical trial of adults who
met the clinical criteria for opioid dependence and
were considered stable after prior buprenorphine
treatment. A response to MAT was measured by
urine screening and self-reporting of illicit opioid use
during the six month treatment period. Sixty-three
percent of Probuphine-treated patients had no evi-
dence of illicit opioid use throughout the six months
of treatment – similar to the 64 percent of those
who responded to sublingual (under the tongue) bu-
prenorphine alone.
The most common side effects from treatment with
Probuphine include implant-site pain, itching, and
redness, as well as headache, depression, consti-
pation, nausea, vomiting, back pain, toothache and
oropharyngeal pain. The safety and efficacy of Pro-
buphine have not been established in children or ad-
olescents less than 16 years of age. Clinical studies
of Probuphine did not include participants over the
age of 65.
Probuphine has a boxed warning that provides im-
portant safety information for health care profes-
sionals, including a warning that insertion and re-
moval of Probuphine are associated with the risk of
implant migration, protrusion, expulsion, and nerve
damage resulting from the procedure. Probuphine
must be prescribed and dispensed according to the
Probuphine REMS program because of the risks of
surgical complications and because of the risks of
accidental overdose, misuse and abuse if an implant
comes out or protrudes from the skin. As part of
this program, Probuphine can only be prescribed
and dispensed by health care providers who are cer-
tified with the REMS program and have completed
live training, among other requirements.
Probuphine implants contain a significant amount
of drug that can potentially be expelled or removed,
resulting in the potential for accidental exposure or
intentional misuse and abuse if the implant comes
out of the skin. Patients should be seen during the
first week after insertion and a visit schedule of no
less than once-monthly is recommended for contin-
ued counseling and psychosocial support.
Probuphine is marketed by San Francisco-based Ti-
tan Pharmaceuticals Inc. and Braeburn Pharmaceu-
ticals based in Princeton, New Jersey.
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