FDA approves ZTlido transdermal patch for post-herpetic neuralgia.- Scilex Pharma.

Scilex Pharmaceuticals received approval from the FDA for ZTlido (lidocaine topical system) 1.8% for the relief of pain associated with post-herpetic neuralgia (PHN), also referred to as post-shingles pain. ZTlido is a major advancement in analgesics because of its proprietary adhesion technology demonstrating 12-hour wear with efficient lidocaine delivery, even during exercise.

According to the FDA adhesion is the most widely reported quality defect of transdermal patches. So ZTlido was specifically designed to maintain optimum skin contact throughout the 12-hour administration period. ZTlido adhesion performance was demonstrated in a clinical study in fifty-four healthy volunteers where forty-seven subjects (87%) had adhesion scores of 0 (at least 90% adhered; essentially no lift off the skin) for all evaluations performed every 3 hours during the 12 hours of administration, and seven (7) subjects (13%) had adhesion scores of 1 (at least 75% up to 90% adhered; some edges only lifting off the skin) for at least one evaluation, and no subjects had scores of 2 or greater (less than 75% adhered).

In the same study 91% (49) of the subjects presented with a score of 0 at the end of the 12-hour administration period. The remaining 5 subjects had a score of 1. In a separate Phase I comparative adhesion study in normal healthy subjects (n=44), ZTlido demonstrated superior adhesion to Lidoderm at 3 hours that improved over the 12-hour administration period.