Heron's post-surgery painkiller swoops into Phase 3
- San Diego biotech Heron Therapeutics is pushing forward with two pivotal trials of its experimental painkiller HTX-011, following an end-of-Phase-2 meeting with the Food and Drug Administration the company described as "positive."
- HTX-011 is an extended-release formulation of the local anesthetic bupivacaine together with the anti-inflammatory agent meloxicam. Heron hopes to position the drug as a non-opiod analgesic alternative for managing post-surgery pain.
- The biotech has already begun recruitment for the two Phase 3 trials investigating HTX-011 following bunionectomy and hernia repair. If all goes according to plan, Heron expects to file a New Drug Application with the FDA before the end of 2018.
Opioid addiction is a growing challenge in the U.S. Overdose deaths from prescription opioids have quadrupled since 1999 and, in 2015, more than 15,000 Americans died from overdoses tied to the powerful drugs.
In that context, scrutiny has grown over the over-use of such drugs to manage pain following surgical procedures — leading drugmakers like Heron to explore development of non-opiod analgesics.
The FDA, too, has stepped up its efforts to combat the epidemic and is taking a harder look at prescribing. "I believe there are still too many thirty-day prescriptions being written for conditions like dental procedures or minor surgery, which should require very short-term use, if they require an opioid prescription at all," said FDA Commissioner Scott Gottlieb in remarks at the regulator's scientific meeting on opioids in July.
In that speech, Gottlieb also said current Risk Evaluation and Mitigation Strategy requirements on extended-release opioid analgesics would be extended to manufacturers of immediate-release opioids.
With HTX-011, Heron aims to reduce the need for systemically administered pain medications such as opiods and add a new treatment option for physicians.
The Phase 3 trials are designed to support a broad indication and will measure pain intensity compared with placebo or with bupivacaine.
The endpoints for the Phase 3 trials, designed to support a broad indication for the reduction of post-operative pain, will look at pain intensity compared with placebo or with bupivacaine. Bunionectomy and hernia-repair were chosen to represent a bony and soft tissue model for HTX-011, respectively.
Other companies, such as Durect Corp., are developing similar treatments for post-surgical pain. Novartis' Sandoz unit recently snapped up U.S. development and commercialization rights to Durect's Posimir (bupivacaine) for $20 million upfront, with milestones of up beyond another $270 million.
Durect plans to resubmit an application based on data from the PERSIST Phase 3 trial in laparoscopic cholecystectomy patients, compared with placebo or bupivacaine.
- Heron Therapeutics Press release
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