Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
As a condition to the Agreement, the Company's 2004 Note in the principalamount of $5.0 million was amended to, among other things, extend the maturitydate to December 31, 2008 from September 30, 2007 and to set the interest rateat 10% from the prior rate of prime rate plus 4.5% (currently 12.75%). A moredetailed description of this equity financing may be reviewed in the Company'sForm 8-K filed with the Securities and Exchange Commission.
Use of Proceeds
The Company will utilize a portion of the net proceeds from thetransaction described above to fund Study 105, the pivotal phase 3 trial forOxyADF (oxycodone HCl and niacin) Tablets, its lead product candidateutilizing Aversion(R) Technology. Study 105 is a randomized, double-blind,placebo-controlled, multicenter, repeat-dose study of the safety and efficacyof OxyADF Tablets for the treatment of acute, moderate to severe postoperativepain following bunionectomy surgery in adult patients. This is a 3-armclinical trial comparing two dose levels of OxyADF Tablets to placebo. Studymedication will be administered to patients every six hours for 48 hoursfollowing the onset of moderate to severe pain following bunionectomy surgery.Study 105 is targeted to enroll 135 patients per arm (approximately 405patients in total). As previously announced, the Company executed a ClinicalTrial Development Agreement with a leading Contract Research Organization andcommenced preliminary Study 105 start-up activities. However, initiation ofpatient enrollment in Study 105 remained dependent upon the availability ofadequate funding. Now that new funding has been secured, the Company intendsto proceed with patient enrollment in Study 105. The Company believes thecompletion of Study 105 is the critical time and events path to a 505(b)(2)NDA submission for OxyADF Tablets.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engagedin research, development and manufacture of innovative Aversion(R) (abusedeterrent) Technology and related product candidates.
Forward Looking Statements
This press release contains "forward-looking statements" as defined in thePrivate Securities Litigation Reform Act of 1995. These statements are basedon current expectations of future events. If underlying assumptions proveinaccurate or unknown risks or uncertainties materialize, actual results couldvary materially from the Company's expectations and projections. The mostsignificant of such risks and uncertainties include, but are not limited to,the Company's ability to secure additional financing to fund operations, theCompany's ability to enter into contractual arrangements with qualifiedpharmaceutical partners to license, develop and commercialize the Company'stechnology and product candidates, the Company's ability to avoid infringementof patents, trademarks and other proprietary rights or trade secrets of thirdparties, and t
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