SOUTH SAN FRANCISCO, Calif.,
June 4, 2019 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced
that it has executed a pharmacy services agreement with Southside
Specialty Pharmacy, further expanding access to treatment with
Probuphine (buprenorphine) implant, Titan's novel maintenance
treatment for Opioid Use Disorder (OUD) in eligible patients.
"We are looking forward to working with Titan to provide
patients with a unique, long-term maintenance treatment option for
OUD," said Southside's Chief Executive Officer, Amit Jain. "California and Texas reported the nation's fourth- and
sixth-highest number of opioid-related deaths, respectively, in
2017.1 With a large, established location in
California, and numerous locations
across Texas, we are proud to
partner with Titan to positively impact OUD patients in our
geographies."
"We are pleased to add Southside as one of Titan's valued
specialty pharmacy partners, particularly given its strong presence
in important markets in California
and Texas," said Titan's Chief
Commercial Officer, Dane Hallberg.
"This partnership with Southside adds regional strength and
reflects our ongoing effort to expand our network with additional
well-established specialty pharmacies."
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.
Titan announced specialty pharmacy agreements with AllianceRx
Walgreens Prime in February 2019 and
Accredo® specialty pharmacy, a subsidiary of Express
Scripts, in May 2019.
1National Center for Health Statistics. (2019,
January 10). Retrieved from
https://www.cdc.gov/nchs/pressroom/sosmap/drug_poisoning_mortality/drug_poisoning.htm
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, normally 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 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.