FDA Approval Secured by San Diego Biotech

Biotech in San Diego On Thursday, the Food and Drug Administration (FDA) gave Heron Therapeutics approval for a drug that relieves post-surgical pain. Zynrelef, as the drug is called, reduces inflammation and pain signals in the region where a surgeon has made a cut. The drug has been shown in clinical trials to minimise the need for strong and possibly addictive opioids.

Heron has now received FDA approval for its third product, after years of back-and-forth with the agency. With those issues addressed, Zynrelef CEO Barry Quart believes the company will be able to help millions of surgical patients each year. Quart said, “We think that this is really an opportunity to completely change how pain management is done. It’s also an opportunity to dramatically reduce the amount of opiates that go home with (patients).”

Heron’s new emphasis on pain management is a departure from the company’s previous products, which were designed to relieve nausea and vomiting caused by chemotherapy. One of these drugs employs a polymer, which is a gel-like mixture of molecules, to ensure that the active ingredient is released slowly, thus extending the drug’s benefits.

Quart was searching for new ways to use this technique, and pain management seemed like a good fit. If you’ve ever sat in a dentist’s chair for a root canal or a deep cleaning, you know that local anaesthesia can make otherwise unpleasant procedures more bearable. When the anaesthetic wears off, the aching normally begins hours later.

The company reasoned that extending pain relief for a few days after surgery, when pain is at its peak, would make patients more relaxed and reduce their need for opioids. Zynrelef, which contains bupivacaine, a popular local anaesthetic that lasts up to eight hours, is based on this concept. The medication is delivered by Heron over a 72-hour period for two reasons.