PALATINE, Ill., Oct. 3, 2005 (PRIMEZONE) -- Acura Pharmaceuticals, Inc. (OTCBB:ACUR) today announced that the Company has received correspondence from the United States Food and Drug Administration ("FDA") recommending certain non-clinical studies be conducted prior to conducting further clinical testing of the Company's Product Candidate No. 2. The Company is therefore suspending the initiation of future clinical trials for Product Candidate No. 2 until the Company is able to more fully evaluate the basis for, and implications of, the FDA's recommendations. The Company intends to request a meeting with the FDA as quickly as possible to discuss all development requirements for Product Candidate No. 2. At this time no meeting date with FDA has been established.
Cash Reserves Update
The Company estimates that its current cash reserves will fund continued development of Product Candidate No. 2 and related operating expenses through October 2005. To continue operating, the Company must raise additional financing or enter into appropriate collaboration agreements with third parties providing for cash payments to the Company. No assurance can be given that the Company will be successful in obtaining any such financing or in securing collaborative agreements with third parties on acceptable terms, if at all, or if secured, that such financing or collaborative agreements will provide for payments to the Company sufficient to continue funding operations. In the absence of such financing or third-party collaborative agreements, the Company will be required to scale back or terminate operations and/or seek protection under applicable bankruptcy laws.
Acura Pharmaceuticals, Inc., together with its subsidiaries, is an emerging pharmaceutical technology development company specializing in proprietary opioid abuse deterrent formulation technology.
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, as amended that are based on management's beliefs and assumptions, current expectations, estimates and projections. Investors are cautioned that forward-looking statements involve risks, uncertainties and other factors, which could cause actual results to differ materially from future results expressed or implied by such forward-looking statements. The most significant of such factors include, but are not limited to, general economic conditions, competitive conditions, technological conditions and governmental legislation. More specifically, important factors that may affect future results include, but are not limited to: changes in laws and regulations, particularly those affecting the Company's operations; the Company's ability to continue to attract, assimilate and retain highly skilled personnel; its ability to secure and protect its patents, trademarks and proprietary rights; litigation or regulatory action that could require the Company to pay significant damages or change the way it conducts its business; the Company's ability to successfully develop and market its products; customer responsiveness to new products and distribution channels; its ability to compete successfully against current and future competitors; its dependence on third-party suppliers of raw materials; the availability of controlled substances that constitute the active ingredients of the Company's products in development; difficulties or delays in clinical trials for Company products or in the manufacture of Company products; and other risks and uncertainties detailed in Company filings with the Securities and Exchange Commission. The Company is at an early stage of development and may not ever have any products that generate significant revenue.
Further, the forward-looking statements speak only as of the date of such statements are made, and the Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Any or all of the forward-looking statements whether included in this release or in the Company's filings with the Securities and Exchange Commission, may turn out to be wrong. Readers should remember that no forward looking statement can be guaranteed and other factors besides those listed above could adversely affect the Company, its operating results or financial condition.
This and past press releases for Acura Pharmaceuticals, Inc. are available at Acura's web site at www.acurapharm.com.