Specialty pain meds maker Scilex Pharmaceuticals plans to wrap up clinical trials for its lead product, Ztildo – and has just raised $5 million from private investors to do so, according to regulatory filings.
Ztildo is a lidocaine patch developed specifically for a form of neuralgia that often follows shingles infections. It has licensed the technology from a Japanese drugmaker it chooses to keep anonymous.
The company, founded in 2012, is based in the greater Philly area. Scilex CEO Anthony Mack spoke with the Philadelphia Business Journal about the company’s plans:
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The drug, if approved, would compete in a market expected to open up with next year’s patent expiration of Lidoderm, a lidocaine patch developed and marketed by Endo. Endo (NASDAQ: ENDP), based in Dublin, Ireland, has its U.S. headquarters in Malvern.
Mack said the drug-delivery system technology they are using allows for Ztlido to be formulated with just a fraction of the dose of lidocaine found in Lidoderm.
The company’s plan is to complete clinical testing of Ztildo later this year, file a new drug application for the product with the Food and Drug Administration at the start of next year, and — if regulatory approval is secured — launch the product as soon as late 2015.
The CDC estimates about one in three people will develop shingles at some point in their lifetime, and between 10 to 18 percent of these will develop this post-herpetic neuralgia. This can cause burning, stabbing or shooting pain sensations that are hard to treat – so the Band-Aid-thin Ztildo is aimed at making the pain go away.
Scilex estimates the Lidoderm brand has created a market opportunity in excess of $1 billion.
