FDA approves Sorrento's non-opioid painkiller patch
Sorrento Therapeutics Inc said the U.S. Food and Drug Administration (FDA) has approved ZTlido, its non-opioid painkiller patch for nerve pain related to shingles, which it plans to launch later this year.
The non-opioid drug is expected to benefit from the strong backlash sellers and prescribers of addictive painkillers have been facing in the United States.
ZTlido, which Sorrento added as part of its 2016 acquisition of majority stake in privately-held SCILEX Pharmaceuticals Inc, was approved for postherpetic neuralgia (PHN), a common complication of shingles that manifests as a burning pain.
“Post herpetic neuralgia is a perfect example of why we have an opioid crisis,” William Pedranti, chief operating officer at SCILEX told Reuters.
The Centers for Disease Control and Prevention (CDC) estimates over 100 Americans die every day from opioid-related overdoses. Last year, U.S. President Donald Trump declared the opioid crisis a public health emergency.
The treatment’s approval puts the bandage-like patch into a market currently split between Endo International Plc’s Lidoderm, which has been on the market for nearly 20 years, and generic versions of that product.
ZTlido improves upon Lidoderm by offering better adhesion and delivers equivalent doses of the pain-relieving active ingredient, lidocaine, more effectively, the company said.
“We’re not saying that it (ZTlido) is a massively better product,” Raghuram Selvaraju, an analyst at H.C. Wainwright said. “It is an incrementally better product, which we believe, is going to be actively promoted.”
Selvaraju expects U.S. sales of the drug to peak at $1.1 billion in 2025.
The FDA had previously rejected ZTlido in 2016.
Shingles, characterized by painful rash, is caused by the reactivation of the chickenpox virus in patients who have suffered from the disease in the past.
Nearly 1 in 3 people in the United States will develop shingles, also known as herpes zoster, during their lifetime, according to the CDC.
(Reporting by Tamara Mathias in Bengaluru; Editing by Arun Koyyur)