PRINCETON, N.J. and SOUTH
SAN FRANCISCO, Calif. and
MONTREAL, Oct. 28, 2016 /PRNewswire/ -- Braeburn
Pharmaceuticals, Inc. and Titan Pharmaceuticals, Inc. (NASDAQ:
TTNP) today announced that three Probuphine presentations were
featured at the International Society of Addiction Medicine (ISAM)
annual meeting in Montreal last
week. Probuphine, a subdermal implant, is the first commercially
available six-month maintenance treatment for opioid
dependence.
According to the World Health Organization (WHO), an estimated
69,000 people die from opioid overdose each year worldwide.
Addiction medicine professionals from around the world met at
ISAM's 18th annual meeting to exchange ideas and explore
new, innovative approaches to treating addiction. Probuphine was
featured prominently among the 200 abstracts and 30 posters
selected by ISAM. Specific presentations included:
- Risk Evaluation and Mitigation Strategy (REMS) program
data: A description of the Probuphine REMS program that was
implemented to train and certify healthcare providers to prescribe
and implant Probuphine. As part of the REMS program, healthcare
providers are required to successfully complete the program prior
to implanting or prescribing Probuphine. The first groups of
healthcare providers were trained two days after Probuphine was
FDA-approved on May 26, 2016. A total
of 2,400 healthcare providers were certified in the first eight
weeks after approval. The trained Probuphine providers practice
across specialties including family medicine/general practice,
psychology/neurology, anesthesiology, and emergency medicine, among
others.
- Buprenorphine implants, extended-release injectable
naltrexone and sublingual buprenorphine were evaluated using a
Markov Model. Buprenorphine implants were found to have
clinical and economic benefits in clinically stable adults due to
little or no potential for abuse or diversion and the sustained
delivery of buprenorphine for up to six months. An earlier version
of this data was featured as a poster presentation at the Academy
of Managed Care Pharmacy (AMCP) annual meeting in April 2016
- Probuphine Pivotal Trial Results: Data from this
landmark double-blind, double-dummy trial were the basis for
Braeburn's New Drug Application that led to FDA approval of
Probuphine, which was developed using ProNeura™, Titan's long-term
continuous drug delivery platform. These data were presented
earlier this year at the American Society of Addiction Medicine
(ASAM) annual meeting in April 2016
and also published in the Journal of American Medical
Association (JAMA) in July 2016.
Highlights included data that showed clinically-stable patients
were maintained over a six-month period when transferred to
Probuphine. In addition, 96.4% of patients using Probuphine
remained free from illicit opioid use over the six-month course of
treatment.
"Sparking conversation and educating the global addiction
medicine leaders on the potential value of Probuphine is essential
to making the treatment available to more patients and providers,"
said Behshad Sheldon, President and
CEO, Braeburn Pharmaceuticals. "The continued interest and
discussion about Probuphine at forums like ISAM's annual meeting
indicates the need for more treatment options to better customize
care for individual patients."
"As the only six-month long-term maintenance treatment for
opioid dependence on the market today, Probuphine stands to play a
significant role in treating opioid addiction," said Sunil Bhonsle, President and CEO, Titan. "We are
pleased with the strong interest the medical community has
expressed in Probuphine at forums such as ISAM, and during the
successful training program implemented by Braeburn, and look
forward to seeing Probuphine become more accessible to providers
and patients."
About Probuphine
Probuphine is the only six-month treatment for opioid dependence
that delivers buprenorphine continuously using Titan
Pharmaceuticals' (NASDAQ: TTNP) ProNeura™ technology. Probuphine is
placed under the skin of the upper arm during an outpatient office
procedure and is removed in a similar manner. Probuphine is
available through a closed distribution system. To learn more about
how to obtain visit:
www.braeburnaccessprogram.com. Qualified healthcare providers
can register for Probuphine training at www.probuphineREMS.com or
by calling 1-866-397-8939. Probuphine is available in all 50 U.S.
States; people interested in finding a provider in their area can
visit www.probuphinerems.com/probuphine-locator.
Probuphine Indication and Important Safety
Information
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 of a transmucosal
buprenorphine-containing product (i.e., doses of no more than 8 mg
per day of Subutex or Suboxone sublingual tablet or generic
equivalent).
PROBUPHINE should be used as part of a complete treatment
program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to treatment and
patients who have not achieved and sustained prolonged clinical
stability, while being maintained on buprenorphine 8 mg per day or
less of a Subutex or Suboxone sublingual tablet or generic
equivalent.
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE
DAMAGE ASSOCIATED WITH INSERTION and REMOVAL
Risk Associated with Insertion and Removal
Insertion and removal of PROBUPHINE are associated with the
risk of implant migration, protrusion, expulsion resulting from the
procedure. Rare but serious complications including nerve damage
and migration resulting in embolism and death may result from
improper insertion of drug implants inserted in the upper arm.
Additional complications may include local migration, protrusion
and expulsion. Incomplete insertions or infections may lead to
protrusion or expulsion.
Because of the risks associated with insertion and removal,
PROBUPHINE is available only through a restricted program called
the PROBUPHINE REMS Program. All Healthcare Providers must
successfully complete a live training program on the insertion and
removal procedures and become certified, prior to performing
insertions or prescribing PROBUPHINE implants. Patients must be
monitored to ensure that PROBUPHINE is removed by a healthcare
provider certified to perform insertions.
Please see additional Important Safety Information in the
Package Insert that can be found at probuphine.com or by following
this link
http://probuphinerems.com/wp-content/uploads/2016/02/final-approved-pi.pdf.
About Opioid Use Disorder and Buprenorphine
Opioid use disorder is a chronic brain disease and one of the
fastest growing public health epidemics in America. In the U.S.,
2.6 million people struggle with opioid addiction and, according to
the Centers for Disease Control, 78 people die each day from the
disease. There is a growing body of evidence that opioid addiction
is not a choice or a moral failing, but the result of genetic
predisposition combined with environmental factors. Nonetheless,
individuals struggling with this disease continue to be
stigmatized. Research has also shown that opioid use disorder is
best treated with a combination of medication and psychosocial
support. The majority of individuals with opioid addiction cannot
sustain recovery without long-term, outpatient medical
treatment.
Buprenorphine is a partial opioid agonist, which may help
individuals to stop opioid use without experiencing withdrawal
symptoms. Before FDA approval of Probuphine, buprenorphine was only
available in oral form which must be taken daily.
About Braeburn Pharmaceuticals
Braeburn
Pharmaceuticals, an Apple Tree Partners company, is a
commercial-stage pharmaceutical company delivering individualized
medicine in neuroscience. Long-acting therapeutic treatment options
can be essential to improving patient outcomes and facilitating
recovery in neurological and psychiatric disorders, which are often
complicated by stigma and present significant public health
challenges. Probuphine, Braeburn's long-acting buprenorphine
implant, was approved by the FDA in May
2016. Braeburn's investigational product pipeline consists
of long-acting, implantable and injectable therapies for serious
neurological and psychiatric disorders, including opioid addiction,
pain, and schizophrenia. Braeburn's pipeline products are at
various stages of clinical development and include CAM2038, weekly
and monthly subcutaneous injection depot formulations of
buprenorphine, being investigated in opioid addiction and pain; and
a risperidone six-month implant being investigated in
schizophrenia. More information on Braeburn, can be found at
www.braeburnpharmaceuticals.com.
About Titan Pharmaceuticals
Titan Pharmaceuticals Inc.
(NASDAQ: TTNP), based in South San
Francisco, CA, is a specialty pharmaceutical company
developing proprietary therapeutics primarily for the treatment of
serious medical disorders. The company's lead product candidate is
Probuphine®, a novel and long-acting formulation of buprenorphine
for the long-term maintenance treatment of opioid dependence.
Probuphine employs Titan's proprietary drug delivery system
ProNeura™, which is capable of delivering sustained, consistent
levels of medication for three months or longer. Titan has granted
commercial rights for the U.S. and Canada for Probuphine to Braeburn
Pharmaceuticals. Approved by the FDA 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 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.
Contacts:
Sherry
Feldberg for Braeburn Pharmaceuticals
MSLGROUP
781-684-0770
braeburnpharma@mslgroup.com
Titan Pharmaceuticals, Inc.
Sunil Bhonsle
President
(650)-244-4990
Investors:
Stephen Kilmer
(650) 989-2215
skilmer@titanpharm.com
Media:
Susan Thomas
(650) 989-2216
sthomas@titanpharm.com
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SOURCE Braeburn Pharmaceuticals; Titan Pharmaceuticals