Titan Pharmaceuticals Announces Agreement in Principle on Path Forward for Probuphine Clinical Study
March 03 2014 - 7:00AM
Marketwired
Titan Pharmaceuticals Announces Agreement in Principle on Path
Forward for Probuphine Clinical Study
SOUTH SAN FRANCISCO, CA--(Marketwired - Mar 3, 2014) - Titan
Pharmaceuticals, Inc. (OTCBB: TTNP) today announced that the
company and its partner, Braeburn Pharmaceuticals, have agreed in
principle with the U.S. Food and Drug Administration (FDA) on the
design of a clinical study in support of the New Drug Application
(NDA) for Probuphine®, the company's investigational subdermal
implant for the maintenance treatment of opioid dependence. The
proposed clinical study will be a randomized, double blind and
double dummy design that will provide information for a
non-inferiority comparison of a six-month treatment with a dose of
four Probuphine implants to treatment with 8mg or less of an
approved daily dosed sublingual formulation of buprenorphine.
Details of the study, including size and the data analysis plan,
will be established following the FDA's review of a complete study
protocol, which Braeburn expects to submit within the next two
weeks.
"We are pleased that there is general agreement on the clinical
study," said Dr. Kate Glassman-Beebe, executive vice president and
chief development officer. "This study design provides the best
opportunity for an unbiased comparison of treatment with Probuphine
to the current standard of care practice, while making sure all
patients will receive active treatment for the disease."
Titan and Braeburn submitted a detailed clinical study synopsis
to the FDA several weeks ago, following discussions with the FDA in
November 2013 regarding the Complete Response Letter issued to the
Probuphine NDA. These discussions and feedback from the FDA led to
the study design described above.
About Opioid Dependence According to recent estimates, there are
2.2 million people with opioid dependence in the U.S. Approximately
20 percent of this population is addicted to illicit opioids, such
as heroin, and the other 80 percent to prescription opioids, such
as oxycodone, hydrocodone, methadone, hydromorphone and codeine.
Before the year 2000, medication-assisted therapies for opioid
dependence had been sanctioned to a limited number of facilities in
the U.S. The Drug Addiction Treatment Act of 2000 (DATA 2000)
allowed medical office-based treatment of opioid dependence and
greatly expanded patient access to medication-assisted treatments.
As a result, an estimated 1.2 million people in the U.S. sought
treatment for opioid dependence in 2011.
About Probuphine Probuphine is an investigational subdermal
implant designed to deliver continuous, around the clock blood
levels of buprenorphine for six months following a single
treatment, and to simplify patient compliance and retention.
Buprenorphine, an approved agent for the treatment of opioid
dependence, is currently available in the form of daily dosed
sublingual tablets and film formulations, with reported 2012 sales
of $1.5 billion in the United States.
Probuphine was developed using ProNeura™, Titan's continuous
drug delivery system that consists of a small, solid implant made
from a mixture of ethylene-vinyl acetate (EVA) and a drug
substance. The resulting construct is a solid matrix that is placed
subdermally, normally in the upper arm in a simple office
procedure, and removed in a similar manner at the end of the
treatment period. The drug substance is released slowly and
continuously through the process of dissolution resulting in a
steady rate of release.
The efficacy and safety of Probuphine has been studied in
several clinical trials, including a 163-patient,
placebo-controlled study over a 24-week period (published in the
Journal of the American Medical Association (JAMA)), and a
follow on study of 287 patients (published in the journal
Addiction).
About Titan Pharmaceuticals For information concerning Titan
Pharmaceuticals, Inc., please visit the Company's website at
www.titanpharm.com.
The 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
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.
CONTACT: Investors: Titan Pharmaceuticals, Inc. Sunil Bhonsle
President (650) 244-4990 Media: Susan Thomas (619) 540-9195
stcommunications@aol.com
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