ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR) Files An 8-K Regulation FD Disclosure
Item 7.01
| Regulation FD Disclosure. |
On June 29, 2017, we will hold a webcast at 8:30 am ET to discuss
the results from clinical study AP-LTX-401, a randomized, fasted,
crossover design pharmacokinetic study testing our LIMITx
formulation LTX-04P3 in healthy adult subjects. The slides to be
discussed on the webcast are attached as Exhibit 99.1.
The webcast may be accessed by visiting the Companys website,
Acurapharm.com and selecting the News and Events option under the
Investors tab. For those wishing to listen only you may dial
1-800-310-1961 with passcode . A replay
of the webcast will be available for 60 days on the Acura
website.
Forward-Looking Statements
Certain statements in sides 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:
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our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx and Impede technologies; |
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the projected period over which funding will be provided from our private placement transaction; |
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the expected results of clinical studies relating to LTX-04 or any successor product candidate, the date by which such study will complete and the results will be available and whether LTX-04 or any successor product candidate will ultimately receive FDA approval; |
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whether LIMITx will retard the release of opioid active ingredients as dose levels increase; |
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whether we will be able to reformulate LTX-04 or any successor product candidate to provide an efficacious level of drug when one or two tablets are taken; |
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whether a reformulated LIMITx formulation that achieves an efficacious level of drug will continue to demonstrate acceptable abuse deterrent performance; |
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whether we will be able to reformulate LTX-04 or any successor product candidate to improve its abuse deterrent performance; |
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whether the extent to which products formulated with the LIMITx technology deter abuse will be determined sufficient by the FDA to support approval or labelling describing abuse deterrent features; |
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our and our licensees ability to successfully launch and commercialize our products and technologies, including Oxaydo Tablets and our Nexafed products; |
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our and our licensees ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies; |
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the market acceptance of, timing of commercial launch and competitive environment for any of our products; |
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our ability to develop and enter into additional license agreements for our product candidates using our technologies; |
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the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties; |
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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; |
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the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates; |
| changes in regulatory requirements; |
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adverse safety findings relating to our commercialized products or product candidates in development; |
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whether the FDA will agree with our analysis of our clinical and laboratory studies; |
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whether further studies of our product candidates will be required to support FDA approval; |
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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 abuse discouraging technologies; and |
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whether Oxaydo or our Aversion and LIMITx product candidates will ultimately deter abuse in commercial settings and whether our Nexafed products and Impede technology product candidates will disrupt the processing of pseudoephedrine into methamphetamine. |
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 theSecurities and Exchange
Commission.
| Item 9.01 | Financial Statements and Exhibits |
Exhibit
| Number | Description |
| 99.1 | Slides |
ACURA PHARMACEUTICALS, INC ExhibitEX-99.1 2 v469769_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 June 28,…To view the full exhibit click here About ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR)
Acura Pharmaceuticals, Inc. is a pharmaceutical company. The Company is engaged in the research, development and commercialization of technologies and products intended to address medication abuse and misuse. The Company has discovered and developed three platform technologies, which can be used to develop multiple products. The Company’s Oxaydo Tablets (oxycodone HCl, CII), which utilizes the Aversion Technology, is an approved and immediate-release (IR) oxycodone product in the United States. The Company’s Impede technology products include Nexafed and Nexafed Sinus Pressure + Pain. Its third deterrent technology is Limitx, which is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. The Company’s Aversion and Limitx technologies are intended to address methods associated with opioid and its Impede technology is directed at the extraction and conversion of pseudoephedrine into methamphetamine.