SOUTH SAN FRANCISCO, Calif.,
Feb. 27, 2017 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), a company
developing proprietary therapeutics for the treatment of select
chronic diseases utilizing its ProNeura™ long-term, continuous drug
delivery platform, today announced that the U.S. Food & Drug
Administration (FDA) has completed its initial review of the
ropinirole implant Investigational New Drug Application (IND) and
has requested that Titan hold the initiation of the clinical study
pending submission of the requested information and the agency's
30-day review.
In a telephone communication with Titan, the FDA indicated that
it will require final release test data on the ropinirole implant
and the applicator used to insert the implant before clearing the
IND. Additionally, the FDA is requesting that Titan identify a
participating Principal Investigator for the study. Titan expects
to have final test data on the implant and the applicator within
the next several weeks, and is in the process of qualifying the
participating clinical sites. The FDA informed Titan that its
written comments on the IND will be sent within the next 30
days.
"We understand the FDA's diligence and respect its request for
additional information," said Titan Executive Vice President and
Chief Development Officer Kate
Beebe, Ph.D. "We are working quickly to provide the FDA with
the additional information required, and are hopeful that we will
be able to commence the clinical study toward the end of the second
quarter."
About Titan Pharmaceuticals
Titan Pharmaceuticals Inc.
(NASDAQ: TTNP), based in South San
Francisco, CA, is developing proprietary therapeutics
primarily for the treatment of serious medical disorders. The
company's lead product 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 in the U.S.
and Canada for Probuphine to
Braeburn Pharmaceuticals. 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 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.
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
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, President and CEO
(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 Titan Pharmaceuticals, Inc.