Heron Therapeutics Initiates Second Phase 2 Clinical Trial of HTX-011 for the Treatment of Post-Operative Pain
07/23/2015
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- HTX-011 to be evaluated in approximately 60 patients undergoing inguinal hernia repair
The placebo-controlled, dose-finding, Phase 2 clinical trial in approximately 60 patients undergoing inguinal hernia repair will evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. HTX-011 is also currently being evaluated in a placebo-controlled, dose-finding, Phase 2 clinical trial in patients undergoing bunionectomy. In a previously completed, placebo-controlled, Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam, with therapeutically relevant plasma bupivacaine levels sustained for 2-3 days.
“We are extremely pleased to be expanding our Phase 2 development program for HTX-011 with the initiation of a study in patients undergoing hernia repair,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “Our ongoing clinical trial in patients undergoing bunionectomy is progressing extremely well, supporting the expansion of the HTX-011 Phase 2 development program. We look forward to reporting data from both the bunionectomy study and the hernia repair study in the second half of 2015.”
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. In a Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam. Specifically, therapeutically relevant plasma bupivacaine levels were sustained for 2-3 days. The anesthetic effects of HTX-011 persisted through 96 hours, which closely correlated with plasma bupivacaine concentrations, and HTX-011 was well-tolerated with no serious adverse events. Heron is currently conducting two placebo-controlled, dose-finding, Phase 2 clinical trials of HTX-011 in patients undergoing bunionectomy or inguinal hernia repair. Heron expects to report results from both of these trials in the second half of 2015.
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Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially. These risks and uncertainties include, but
are not limited to, those associated with: the acceptance of the
Company’s resubmission of its New Drug Application (NDA) for SUSTOL®,
whether the
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Source:
Investor Relations Contact:
Heron Therapeutics, Inc.
Jennifer
Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
jcapuzelo@herontx.com
or
Corporate
Contact:
Barry D. Quart, 650-366-2626
Pharm.D., Chief
Executive Officer