IntelGenx Updates Status of Buprenorphine Buccal Film ANDA
April 05 2024 - 6:45AM
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or
“IntelGenx”) today announced that its co-developer, Chemo Research
SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has
received a Complete Response Letter (“CRL”) from the U.S. Food and
Drug Administration (“FDA”) regarding its resubmitted abbreviated
new drug application (“ANDA”) for Buprenorphine Buccal Film.
The CRL includes a request for additional
Pharmaceutical Quality information. The FDA confirmed that no
additional inspection of IntelGenx’s facility is required at this
time.
“Our partner is committed to providing the FDA
with a response to the CRL as soon as is practicable,” commented
Dwight Gorham, IntelGenx’s CEO.
Buprenorphine Buccal Film, which incorporates
IntelGenx’s VersaFilm® technology in a novel formulation, is a
generic version of Belbuca®, an opioid that is used to manage
chronic pain severe enough to require daily, around-the-clock,
long-term treatment with an opioid, when other pain treatments are
inadequate. Approved by the FDA in 2015, Belbuca® is applied to the
oral or buccal mucosa every 12 hours and comes in seven strengths
ranging from 0.075 mg to 0.9 mg.
About IntelGenx
IntelGenx is a leading drug delivery company
focused on the development and manufacturing of pharmaceutical
films.
IntelGenx’s superior film technologies,
including VersaFilm®, DisinteQ™, VetaFilm® and transdermal
VevaDerm™, allow for next generation pharmaceutical products that
address unmet medical needs. IntelGenx’s innovative product
pipeline offers significant benefits to patients and physicians for
many therapeutic conditions.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility offers full service by
providing lab-scale to pilot- and commercial-scale production. For
more information, visit www.intelgenx.com.
Forward-Looking Information and
Statements
This document may contain forward-looking
information about IntelGenx's operating results and business
prospects that involve substantial risks and uncertainties.
Statements that are not purely historical are forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, but are not
limited to, statements about IntelGenx's plans, objectives,
expectations, strategies, intentions or other characterizations of
future events or circumstances and are generally identified by the
words "may," "expects," "anticipates," "intends," "plans,"
"believes," "seeks," "estimates," "could," "would," and similar
expressions. All forward looking statements are expressly qualified
in their entirety by this cautionary statement. Because these
forward-looking statements are subject to a number of risks and
uncertainties, IntelGenx's actual results could differ materially
from those expressed or implied by these forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed under
the heading "Risk Factors" in IntelGenx's annual report on Form
10-K, filed with the SEC and available at www.sec.gov, and also
filed with Canadian securities regulatory authorities at
www.sedarplus.com. IntelGenx assumes no obligation to update any
such forward-looking statements.
Source: IntelGenx Technologies Corp.For
IntelGenx:
Stephen KilmerInvestor Relations(647)
872-4849stephen@kilmerlucas.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx
Corp.(514) 331-7440 ext 203andre@intelgenx.com
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