Heron Therapeutics Provides Update on SUSTOL™ Program
06/02/2014
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- SUSTOL™ Phase 3 study in delayed-HEC patients progressing rapidly – over 100 site locations opened in first two months
- Based on faster than expected start-up, Heron now plans to include delayed-HEC results in NDA resubmission planned for fourth quarter
As a consequence of the rapid start-up, results of the delayed-HEC study
are anticipated earlier than previously projected and the Company now
plans to include these results in its resubmission of the new drug
application (NDA) for SUSTOL to the
“I’m very pleased with the excellent start to the delayed-HEC study,”
commented Barry D. Quart, Pharm.D., Chief Executive Officer of
Dr. Quart continued, “While we have successfully completed the Human Factors Validation study and all other requirements for resubmitting the SUSTOL NDA, we believe postponing the resubmission to include the delayed-HEC results will be well worth the long-term benefit of launching SUSTOL with the broadest label.”
About SUSTOL™
Heron's lead product candidate, SUSTOL™ (granisetron), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV in patients receiving highly emetogenic chemotherapy (HEC). SUSTOL contains the 5-HT3 receptor antagonist granisetron formulated in the Company's proprietary Biochronomer™ polymer-based drug delivery platform, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for SUSTOL because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About Heron’s Post-Surgical Pain Program
Heron is utilizing its proprietary Biochronomer™ polymer-based drug delivery platform to develop drugs designed to extend the duration of action of known active ingredients to address important unmet medical needs. The Company has initiated full development of an established local anesthetic for the treatment of post-surgical pain formulated with its Biochronomer extended release technology. In animal models of post-surgical pain, the Company's drug candidates demonstrated statistically significant pain relief for three days, representing the potential to significantly reduce the need for opiates post-surgery and the length of post-surgical hospital stays. Heron’s lead product candidate in this program, HTX-011, is a unique combination of local analgesic agent bupivacaine and the anti-inflammatory drug meloxicam utilizing its Biochronomer extended release technology. Heron expects to move this program into human clinical studies in the second half of 2014.
About
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties, including
uncertainties associated with the potential approval of SUSTOL™
and the potential timing for such approval, if approved at all; risks
relating to progress in research and development of HTX-011, including
the timing of planned toxicology and clinical studies; risks related to
other programs; risks related to the launch and acceptance of new
products and other risks and uncertainties identified in the Company's
filings with the
Source:
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
jcapuzelo@herontx.com
and
Corporate
Contact:
Stephen R. Davis, 650-366-2626
Executive Vice
President and Chief Operating Officer