SOUTH SAN FRANCISCO, Calif.,
Sept. 18, 2019 /PRNewswire/
-- National Institutes of Health's National Institute on Drug
Abuse (NIDA) has approved approximately $6.1
million in second-year funding for Titan's non-clinical
development of a ProNeura™ based six-month implantable formulation
of Nalmefene, an opioid antagonist, intended for the prevention of
relapse to opioid addiction, following opioid detoxification.
NIDA awarded Titan a two-year grant in the amount of
$6.7 million in September 2018 for the project, subject to
satisfactory project progress, fund availability and certain other
conditions. The award for the first year, which ended August 31, 2019, was approximately $2.7 million. As a result of a change in the
grant award terms regarding company matching funds, the second-year
award covers both the Federal and company match amounts of the
original year two award, thereby increasing the aggregate potential
expense reimbursement to approximately $8.7
million.
"We believe our ProNeura technology is well-suited to this
approach to treating opioid addiction, so we are grateful for
NIDA's ongoing support," said Titan's President and CEO,
Sunil Bhonsle. "As we continue to
execute on the program's development milestones, we are encouraged
by the potential for additional NIDA grant funding for clinical
development activities beyond the current grant's end date of
September 2020."
This second-year grant award provides funds for the completion
of implant formulation development, cGMP manufacturing and
non-clinical studies which, if successful, are expected to support
the Company's submission of a Nalmefene six-month implant
Investigational New Drug Application to the U.S. Food and Drug
Administration. Titan retains full commercial rights to the
Nalmefene implant product.
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.
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 buprenorphine-containing product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
It is not known if PROBUPHINE is safe or effective in children
less than 16 years of age.
IMPORTANT SAFETY INFORMATION
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, possibly to your lung,
and could lead to death
- Implant sticks out of the skin
(protrusion)
- Implant comes out by itself (expulsion)
|
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
If the implant comes out by itself, keep it away from others,
especially children, as it may cause severe difficulty in breathing
and possibly death.
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 regarding IMPLANT MIGRATION,
PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION
AND REMOVAL.
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.
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.