Titan Pharmaceuticals Receives Official Minutes From FDA Meeting on Probuphine New Drug Application
December 23 2013 - 7:00AM
Marketwired
Titan Pharmaceuticals Receives Official Minutes From FDA Meeting on
Probuphine New Drug Application
SOUTH SAN FRANCISCO, CA--(Marketwired - Dec 23, 2013) - Titan
Pharmaceuticals, Inc. (OTCBB: TTNP) today announced the receipt of
the official minutes (the "Minutes") from a Type C meeting with the
U.S. Food and Drug Administration (FDA) on November 19, 2013 to
discuss the Complete Response Letter (CRL) to its New Drug
Application (NDA) for Probuphine®, an investigational subdermal
implant for the maintenance treatment of opioid dependence in adult
patients. Per the Minutes, the FDA emphasized its commitment to
working with Titan and its partner, Braeburn Pharmaceuticals, to
pursue a reasonable path to approval, and all parties agreed that
seeking an indication in individuals stabilized on 8 mg/day or less
of sublingual buprenorphine (SL BPN) may be a suitable approval
pathway for Probuphine. Titan and Braeburn proposed the revised
indication following a review of the FDA's comments on the briefing
material and to address one of the primary concerns in the CRL
regarding dose adequacy among the original study population (newly
inducted patients maintained at 12-16 mg SL BPN/day). The FDA
maintained the need for clinical data in this patient population as
a requirement for approval, stipulating that the study "need
not be large," "be adequate and well-controlled," and
"must support labeling for the duration of treatment (6
months)." Titan and Braeburn are working with experts
in the field to develop a clinical study design for submission to
the FDA within the next few weeks.
"We appreciate the FDA's close consideration of our proposal
addressing the CRL and its continued support to advance the
Probuphine program," said Sunil Bhonsle, president of Titan
Pharmaceuticals. "While our path forward includes an additional
clinical study, we are encouraged by the FDA's noted willingness to
work closely and iteratively with us on all aspects of the CRL to
ensure a mutually feasible and expeditious path to approval. We
will provide updates to our shareholders on an as needed
basis."
The plan forward for additional items outlined in the April 2013
CRL was also summarized in the Minutes.
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
confirmatory 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: Titan Pharmaceuticals, Inc. Sunil Bhonsle 650-244-4990
President Pure Communications Susan Heins 864-286-9597
sjheins@purecommunicationsinc.com
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