SOUTH SAN FRANCISCO, Calif.,
May 13, 2019 /PRNewswire/ -- Titan
Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced that it has
executed a product purchase and supply agreement with Accredo
specialty pharmacy, a subsidiary of Express Scripts, further
expanding access to treatment with Probuphine (buprenorphine)
implant, Titan's novel maintenance treatment for Opioid Use
Disorder (OUD) in eligible patients.
Titan expects the majority of Probuphine sales in the United States to be through the specialty
pharmacy distribution model, where a specialty pharmacy carries
inventory, directly handles the subsequent patients' insurance
billing and payment processes, and ships to the healthcare provider
as prescribed. This system is designed to facilitate patient access
to treatment by streamlining the product ordering and fulfillment
process for healthcare providers and their staff. In
February 2019, Titan announced a
specialty pharmacy distribution and services agreement with
AllianceRx Walgreens Prime. Titan's strategic expansion of its
network to include Accredo, one of the largest U.S. specialty
pharmacies, is a key component of its focused commercialization
strategy for Probuphine.
"We are proud to partner with Accredo as we expand the specialty
pharmacy distribution network for Probuphine in the United States," said Titan's Chief
Commercial Officer, Dane Hallberg.
"Accredo is among the top specialty pharmacy networks in the U.S.
with excellent relationships with third-party payors that should
enhance the ability of OUD patients to gain access to long-term
maintenance treatment with Probuphine."
Express Script's Advanced Opioid ManagementSM program
received the Pharmacy Benefit Management Institute's excellence
award in the opioid management strategy category in March 2018.
About Probuphine
Probuphine is the only subdermal implant designed to deliver
buprenorphine continuously for six months following insertion.
Probuphine was developed using ProNeura™, the continuous drug
delivery system developed by Titan that consists of a small, solid
implant made from a mixture of ethylene-vinyl acetate and a drug
substance. The resulting construct is a solid matrix that is placed
subdermally in the upper arm in an outpatient office procedure and
removed in a similar manner at the end of the treatment period. The
U.S. Food and Drug Administration ("FDA") approved Probuphine in
May 2016, and it is the first and
only buprenorphine implant available for the maintenance treatment
of opioid addiction in eligible patients.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED
WARNING
Indication
PROBUPHINE is an implant that contains the medicine
buprenorphine. PROBUPHINE is used to treat certain adults who are
addicted to (dependent on) opioid drugs (either prescription or
illegal). PROBUPHINE is indicated for the maintenance treatment of
opioid dependence in patients who have achieved and sustained
prolonged clinical stability on low-to-moderate doses (doses no
more than 8 mg per day) of a transmucosal buprenorphine-containing
product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
WARNING:
COMPLICATIONS FROM INSERTION AND REMOVAL OF
PROBUPHINE
|
See Full
Prescribing Information for complete Boxed Warning
|
|
Serious
complications may happen from insertion and removal of
PROBUPHINE, including:
|
- Nerve or blood vessel injury in your arm
- Movement of implant (migration). PROBUPHINE
or pieces of it can move into blood vessels and to your lung, and
could lead to death.
- Implant sticks out of the skin
(protrusion)
- Implant comes out by itself (expulsion)
|
Contraindications
Hypersensitivity to buprenorphine or any other ingredients in
PROBUPHINE (e.g., EVA).
Call your healthcare provider right away if:
- PROBUPHINE sticks out of the skin or comes out by itself
- You have bleeding or symptoms of infection at the site after
insertion or removal, including excessive or worsening itching,
pain, irritation, redness, or swelling
- You have numbness or weakness in your arm after the insertion
or removal procedure
- You have weakness or numbness in your arm, or shortness of
breath
Because of the risk of complications of, migration, protrusion,
expulsion and nerve injury with insertion and removal of
PROBUPHINE, it is only available through a restricted program
called the PROBUPHINE REMS Program. Healthcare Providers who
Prescribe and/or Insert PROBUPHINE must be certified with the
program by enrolling and completing live training.
- PROBUPHINE is not available in retail pharmacies.
- PROBUPHINE must be inserted or removed only in the facility of
the certified prescriber.
Implants may be difficult to locate if inserted too deeply, if
you manipulate them, or if you gain significant weight after
insertion. Your healthcare provider may do special procedures
or tests, or refer you to a surgical specialist to remove the
implants if they are difficult to locate.
The medicine in PROBUPHINE can cause serious and
life-threatening problems, especially if you take or use certain
other medicines or drugs. Call your healthcare provider right
away or get emergency help if you feel faint or dizzy, have mental
changes such as confusion, slower breathing than you normally have,
severe sleepiness, blurred vision, problems with coordination,
slurred speech, cannot think well or clearly, high body
temperature, slowed reflexes, feel agitated, stiff muscles or have
trouble walking.
These can be signs of an overdose or other serious
problems.
Coma or death can happen if you take anxiety medicines or
benzodiazepines, sleeping pills, tranquilizers, or sedatives,
antidepressants, or antihistamines, or drink alcohol during
treatment with PROBUPHINE. Tell your healthcare provider if you are
taking any of these medicines or if you drink alcohol.
Who should not use PROBUPHINE?
Do not use PROBUPHINE
if you are allergic to buprenorphine or any of its ingredients,
this includes buprenorphine hydrochloride and the inactive
ingredient ethylene vinyl acetate or EVA.
PROBUPHINE may not be right for you. Before starting
PROBUPHINE tell your doctor about all of your medical conditions,
including:
Trouble breathing or lung problems, an
enlarged prostate gland (men), a head injury or brain problem,
problems urinating, a curve in your spine that affects your
breathing, liver problems, gallbladder or adrenal gland problems,
Addison's disease, low thyroid hormone levels (hypothyroidism), a
history of alcoholism, a history of keloid formation, connective
tissue disease (such as scleroderma), or history of MRSA
infections, mental problems such as hallucinations, an allergy to
numbing medicines or medicines used to clean your skin, are
pregnant or plan to become pregnant or are breastfeeding or plan to
breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements.
What should I avoid while being treated with
PROBUPHINE?
- Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how this medication affects
you.
- You should not drink alcohol during treatment. You
should not take anxiety medicines or benzodiazepines, sleeping
pills, tranquilizers, or sedatives that are not prescribed to you
during treatment with PROBUPHINE, as this can lead to slowed
breathing, drowsiness, delayed reaction time, loss of consciousness
or even death.
What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
- Infection at the insertion or removal
site. Infection may happen at the implant site during
insertion or removal. Do not try to remove PROBUPHINE
yourself.
- Opioid withdrawal. If PROBUPHINE comes out of your
arm or if you stop treatment, tell your doctor right away as you
can have symptoms of shaking, sweating more than normal, feeling
hot or cold more than normal, runny nose, watery eyes, goose bumps,
diarrhea, vomiting and muscle aches.
- Physical dependency.
- Liver problems. Call your doctor right away if you
notice signs of liver problems that may include your skin or the
white part of your eyes turning yellow (jaundice)
- Allergic reaction. If you get a rash, hives,
itching, swelling of your face, or wheezing, low blood pressure,
dizziness or decrease in consciousness.
- Decrease in blood pressure. You may feel dizzy when you
get up from sitting or lying down.
Tell your healthcare provider if you develop any of the
symptoms listed.
Common side effects of PROBUPHINE
include: Headache, nausea, toothache, constipation, depression,
vomiting, back pain, mouth and throat pain.
Common risks with the minor surgical procedure:
Itching, pain, irritation, redness, swelling, bleeding, or bruising
at the insertion or removal site. Scarring around the insertion
site.
Please read Full Prescribing Information, including BOXED
WARNING.
Titan encourages you to report negative side effects of
prescription drugs to the FDA. You can visit
www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage
company developing proprietary therapeutics with its ProNeura™
long-term, continuous drug delivery technology. The company's lead
product is Probuphine® (buprenorphine) implant, a novel and
long-acting formulation of buprenorphine for the long-term
maintenance treatment of opioid dependence. Approved by the U.S.
Food and Drug Administration in May
2016, Probuphine is the first and only commercialized
treatment of opioid dependence to provide continuous,
around-the-clock blood levels of buprenorphine for six months
following a single procedure. The ProNeura technology also has the
potential to be used in developing products for treating other
chronic conditions such as Parkinson's disease and hypothyroidism,
where maintaining consistent, around-the-clock blood levels of
medication may benefit the patient and improve medical outcomes.
For more information about Titan, please visit
www.titanpharm.com.
Forward-Looking Statements
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to our
product commercialization and development programs and any other
statements that are not historical facts. Such statements involve
risks and uncertainties that could negatively affect our business,
operating results, financial condition and stock price. Factors
that could cause actual results to differ materially from
management's current expectations include those risks and
uncertainties relating to the commercialization of Probuphine, the
regulatory approval process, the development, testing, production
and marketing of our drug candidates, patent and intellectual
property matters and strategic agreements and relationships.
We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
CONTACTS:
Sunil Bhonsle
President & CEO
(650) 244-4990
Stephen Kilmer
Investor Relations
(650) 989-2215
skilmer@titanpharm.com
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SOURCE Titan Pharmaceuticals, Inc.