Liquid capsaicin formula begins phase II clinical trial.
A study involving a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia, kicked off its phase II clinical trial today by dosing the first patient.
The target profile for NGX-1998 is to provide safety, efficacy, and tolerability that is at least comparable to Qutenza (capsaicin) 8% patch with a significantly shorter application time. NGX-1998 is being developed to provide rapid, localized, and sustained pain relief to treat peripheral neuropathic pain conditions such as PHN.
According to the website, NeurogesX focuses on developing and commercializing novel pain management therapies. The company’s lead product is Qutenza (capsaicin) 8% patch, a dermal delivery system containing a prescription strength of capsaicin that is currently approved in the US and the European Union.
Qutenza is the first and only prescription-strength capsaicin product, according to its website. “It is pure, synthetic capsaicin in a novel, localized dermal delivery system for pain relief.” The product works by acting on the damaged nerves in the skin that cause pain after shingles; here it relieves pain. However, the effects of capsaicin wear off over time.
The Phase 2, adaptive-design, clinical study will be conducted in two stages. The first stage is designed to determine the shortest tolerable anesthetic pretreatment regimen. The second stage will evaluate two NGX-1998 dose concentrations using the pretreatment regimens determined during stage 1. The objective is to select the appropriate concentration of NGX-1998 and pretreatment period for further evaluation in a Phase 3 clinical program. Up to 200 PHN patients are targeted for enrollment.
Jeffrey Tobias, MD, executive vice president for Research and Development and Chief Medical Officer said, in a press release, “We are very pleased to have initiated our Phase 2 study of NGX-1998. Previous Phase 1 studies have suggested that NGX-1998 may deliver an effective dose of capsaicin in as little as five minutes. This study will now explore the shortest tolerable pretreatment regimen as well as provide preliminary efficacy and safety data of two concentrations of NGX-1998 in patients with PHN. These data will help us select the optimal dose of NGX-1998 and shortest overall treatment regimen. NGX-1998 is an important product candidate for the long-term growth of our neuropathic pain franchise and we are happy to have this clinical trial underway.”
Source: NeurogesX--What are the advantages of a liquid formualtion of capsaicin treatment? Leave a comment.