Heron Pharma has new data on its combination anaesthetic drug, and a breakthrough designation from the FDA, which suggests it could have an impact on the post-operative pain market.
Shares in the company jumped by a third yesterday after the latest phase trial and BTD were announced – and on the company’s announcement that it is now pitching at a regulatory filing in the US in the second half of the year.
If approved it will challenge current drugs for post-operative pain including Pacira Pharma’s Exparel (liposomal bupivacaine), which made $283m in sales last year despite the fact that the market segment is largely served by low-cost generic drugs. Pacira shares closed down 14% yesterday on the threat of competition to its biggest-selling product.
Heron’s rival candidate – called HTX-011 – pairs up a new extended-release formulation of the local anaesthetic bupivacaine with meloxicam, a well-established non-steroidal anti-inflammatory drug (NSAID). It’s designed to be more effective and easier to administer than current therapies.
In the latest phase 2b trial, HTX-011 was tested in patients undergoing knee replacement or breast augmentation surgery and was found to significantly reduce pain levels and the use of opioid analgesics compared to both placebo and local anaesthesia monotherapy with bupivacaine in the first 48 hours after surgery.
In the knee replacement patients, HTX-011 delivered into the surgical site by instillation achieved a 19% reduction in pain intensity in the first 48 hours versus placebo, rising to 23% if combined with a low-dose ropivacaine injection. Patients who received multiple bupivacaine injections experienced an 11% reduction, and similar effects for all groups were seen out to 72 hours.
Meanwhile, in the breast augmentation patients, delivery of HTX-011 by instillation or ultrasound-guided lateral and medial pectoral nerve block prior to surgery cut pain intensity by 22% compared to placebo, compared to 8% for bupivacaine injections, after 24 hours.
In March Heron reported positive top-line data from two phase III trials of the drug in patients undergoing surgery for bunion removal and hernia repair, also showing a significant reduction in pain intensity and opioid use compared to placebo and bupivacaine.
The reduction in opioid use is another important facet of the new therapy, given the US’s current epidemic of opioid abuse – with addiction in some cases occurring in people initially prescribed the pain relief for legitimate medical indications.
“HTX-011 is the only long-acting local anaesthetic to demonstrate significantly reduced postoperative pain and opioid use through 72 hours compared to bupivacaine solution, the standard-of-care local anaesthetic for postoperative pain management, in phase III studies,” said Barry Quart, Heron’s chief executive.
The new breakthrough designation adds to an earlier fast-track status for HTX-011 from the FDA, setting up a possible approval in the first half of 2019.
Analysts at Jefferies have suggested Heron’s drug could achieve sales of more than $500m is approved with a superiority claim over bupivacaine solution, while Cantor’s Louise Chem suggested in March that Exparel sales would fall off dramatically if HTX-011 is approved – particularly as she thinks Heron’s drug is likely to be cheaper.