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Evolving the Patient Experience
The
newly released FDA approved Suboxone Film is indicated for maintenance treatment
of opioid dependence and should be used as part of a complete treatment plan to
include counseling and psychosocial support. The prescription use is still
limited under the Drug Addiction Treatment Act, however, this innovation helps
address compliance challenges:
Suboxone Sublingual Film Dissolve Time—Dissolves faster than the
sublingual tablets presently in use.
a). Suboxone Film dissolves completely under the tongue faster than
the
Suboxone Tablet
b). In
clinical trials, Suboxone Film 8 mg dissolved nearly twice as fast as
Suboxone
Tablet 8 mg.
Suboxone Sublingual Film Taste—Favorable taste rating
a). In a
patient questionnaire, more than 71% of patients who tried Suboxone
Film rated
the taste as neutral or better on a
10-point scale.
Portability—Compact unit-dose pouches
a). Unit-dose, child resistant pouches are easy to carry
b). Patients
who carry Suboxone Film with them should be advised to also carry their pharmacy
label
Discount Offer: Limited Time Only
A patient offer for up to $75 in out-of-pocket savings with
the Suboxone Film savings program is available. Information regarding the offer
is available at Winter Park Recovery Center.
Comparable Efficacy and Safety of Suboxone Film
to Suboxone Tablet
Clinically the Suboxone Film is interchangeable with the
Suboxone Tablet.
•
In a clinical study where patients were transferred to Suboxone Film at
their Suboxone Tablet dose
a). The transfer from Suboxone Tablet to Suboxone Film was effective
b). The difference between formulations was not clinically significant
c). 1 out of 176 participants received a dose adjustment (increase) during the
first 2 weeks of the trial
d). Safety trial results indicate that Suboxone Film is well tolerated and has a
safety profile comparable to Suboxone Tablet
• Reduces illicit opioid use and increases treatment retention by suppressing
opioid withdrawal symptoms and reducing
cravings
• Once daily dosing due to a long duration of effect,
just as with Suboxone Tablet
• A dose adjustment may be needed for patients switching
from Suboxone Tablet to Suboxone
Film due to potential individual variability in
bioavailability
• The most common adverse event (>1%) associated with
the sublingual administration of the
Suboxone Film was oral hypoesthesia. Other adverse
events were constipation, glossodynia,
oral erythema, vomiting, intoxication, disturbance in
attention, palpitations, insomnia,
withdrawal syndrome, hyperhidrosis and blurred
vision.
• Patients are able to transfer from Suboxone Tablet to
Suboxone Film easily and effectively.
Suboxone Sublingual Film: Helping Address Public
Health Needs
• Child-resistant unit-dose packaging
a). Pouches achieved a high level of child
resistance
b). Unit-dose packaging to reduce the risk of
multi-dose exposure
• Suboxone Film formulation discourages misuse and abuse
a). Suboxone Film formulation makes it
difficult to crush into a powder and snort
b). Suboxone Film contains
naloxone. If injected, noxalone attenuates the effects of buprenorphine and
precipitates
withdrawal in individuals dependent on full opioid agonists, but
has no effect when taken sublingually
• Protecting treatment through a Risk Evaluation and
Mitigation Strategy (REMS)
a). REMS consists of a set of tactics designed
to help promote the appropriate use of
buprenorphine and help protect the
in-office treatment of opioid dependence
• Includes various materials and processes developed to
assist in:
a). Mitigating the risk of accidental overdose,
misuse, and abuse
b). Informing patients of the serious risks
associated with buprenorphine |