ACURA PHARMACEUTICALS, INC. Item 8.01 - Other Events.
A known hydrocodone derivative continues to be detected in the CRT samples, as
well as, unknown impurities. The unknown impurities remain at levels within
standards typically accepted by the
The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale. The data being generated in the shelf life study is intended to be used to support the manufacturing and shelf life requirements for an NDA. FDA Guidance allows for the use of CRT data to establish shelf life standards for a product.
LTX-03 (hydrocodone bitartrate with acetaminophen)
Recent reports suggest growing numbers of legitimate pain patients are going
undertreated as they can no longer find doctors willing to treat them due to new
prescribing guidelines associated with the opioid epidemic. Suicide is
increasingly seen as the only remedy for some of these patients through opioid
overdose. Our goal with LIMITx is to develop a treatment for effective pain
relief at a one or two tablet dose while providing overdose protection by
limiting high peak levels of drug in the bloodstream (Cmax) that can lead to
respiratory depression and death when more than the recommended dose is
ingested. LIMITx works by neutralizing stomach acid with buffering ingredients
as increasing numbers of tablets are swallowed thereby reducing the stomach acid
available to cause the release and subsequent systemic absorption of the active
ingredient from micro-particles contained in the LIMITx tablets. In a human
clinical study, formulations of LTX-03 demonstrated, under fasted conditions,
analgesic levels of hydrocodone in the blood when taken at a recommended one or
two tablet dose but reduced the maximum blood level (Cmax) up to 34% when
subjects were exposed to higher buffer ingredient levels. Hydrocodone with
acetaminophen remains the single largest prescribed opioid in the
2
Forward-Looking Statements
Statements in this Current Report constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements.
Forward-looking statements may include, but are not limited to:
• our ability to fund or obtain funding for our continuing operations,
including the development of our products utilizing our LIMITx and IMPEDE
technologies;
• whether we will receive FDA acceptance for an NDA for LTX-03 by the target
date;
• whether our licensees will terminate the license prior to commercialization;
• the expected results of clinical studies relating to LTX-03 or any successor
product candidate, the date by which such studies will complete and the
results will be available and whether any product candidate will ultimately
receive FDA approval;
• the ability of LTX-03 single tablets to achieve bioequivalence or to
demonstrate efficacy in a clinical study;
• whether our licensing partners will develop any additional products and
utilize Acura for such development;
• whether LIMITx will retard the release of opioid active ingredients as dose
levels increase;
• whether the extent to which products formulated with the LIMITx technology
mitigate respiratory depression risk will be determined sufficient by the
FDA;
• our and our licensee's ability to successfully launch and commercialize our
products and technologies;
• our and our licensee's ability to obtain necessary regulatory approvals and
commercialize products utilizing our technologies;
• the market acceptance of, timing of commercial launch and competitive
environment for any of our products;
• our ability to develop and enter into additional license agreements for our
product candidates using our technologies;
• the ability to avoid infringement of patents, trademarks and other
proprietary rights of third parties;
• the ability of our patents to protect our products from generic competition
and our ability to protect and enforce our patent rights in any paragraph IV
patent infringement litigation;
• the adequacy of the development program for our product candidates,
including whether additional clinical studies will be required to support an
NDA and FDA approval of our product candidates;
• changes in regulatory requirements;
• adverse safety findings relating to our commercialized products or product
candidates in development;
• whether or when we are able to obtain FDA approval of labeling for our
product candidates for the proposed indications and whether we will be able
to promote the features of our technologies; and
• whether our product candidates will ultimately perform as intended in
commercial settings.
In some cases, you can identify forward- looking statements by terms such as
"may," "will", "should," "could," "would," "expects," "plans," "anticipates,"
"believes," "estimates," "indicates", "projects," "predicts," "potential" and
similar expressions intended to identify forward-looking statements. These
statements reflect our current views with respect to future events and are based
on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking
statements. We discuss many of these risks in greater detail in our filings with
the
3
© Edgar Online, source
