SOUTH SAN FRANCISCO, Calif.,
Oct. 22, 2019 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced
that it has two poster presentations on Probuphine (buprenorphine)
implant, Titan's novel 6-month maintenance treatment for Opioid Use
Disorder ("OUD") in eligible patients, at the 10th
American Conference on Pharmacometrics taking place on October 20-23, 2019 in Orlando, FL.
The poster presentations will provide details of the results
from computer modeling studies that assessed the population
pharmacokinetic ("PK") parameters, exposure-response profiles, and
drug-drug interaction ("DDI") potential of the patient plasma
levels of buprenorphine during treatment with Probuphine subdermal
implants. These analyses are based on data from Titan's PRO-805,
PRO-806, PRO-807, PRO-810 and PRO-811 Phase 3 clinical studies with
Probuphine in subjects with OUD.
"We are pleased to present the findings on Probuphine's PK,
exposure-response and DDI profiles at this conference," said
Titan's Executive Vice President and Chief Scientific Officer,
Kate DeVarney, Ph.D. "The population
PK study found that the only significant demographic impacts on
buprenorphine absorption and clearance from Probuphine treatment
were body mass index and body weight, respectively. The
exposure-response analysis established that there was a plateau for
maximum efficacy at a relatively low range of plasma buprenorphine
concentrations and that the clinical response as measured by urine
testing was not significantly enhanced at higher concentrations in
this Emax model. Finally, the DDI simulation study suggests that
buprenorphine exposure from Probuphine is not significantly
affected by a strong inhibitor of CYP3A4, and is decreased by only
25-30% with a strong inducer of CYP3A4."
Dr. DeVarney continued, "Taken together, these results suggest
that the PK profiles for Probuphine are highly predictable, and
that the maximum clinical benefit of buprenorphine for the
treatment of OUD can be achieved in eligible patients at relatively
low blood concentration levels. Further, the potential for DDI on
buprenorphine exposure from Probuphine is similar to that reported
for other marketed buprenorphine formulations."
Poster Presentation Details:
Poster Presentation #1: Population Pharmacokinetic Modeling and
Exposure-Response Analysis of Probuphine Implants in Opioid Use
Disorder Subjects
Authors: Olivier Barriere, Nathalie H.
Gosselin, and Nada Farhat,
Certara Strategic Consulting; Markus
Jerling, Markus Jerling Consulting AB; and Sunil Sreedharan, Titan Pharmaceuticals,
Inc.
Date: Tuesday, October 22, 2019
Poster Presentation #2: Evaluation of Drug-Drug Interaction
Potential of Probuphine Implants using a Physiologically-Based
Pharmacokinetic Model
Authors: Jogarao Gobburu,
University of Maryland School of
Pharmacy; and Sunil
Sreedharan, Titan Pharmaceuticals Inc.
Date: Wednesday, October 23, 2019
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 inner 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.
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.