31 October 2019 - - US-based non-opioid, lidocaine-free analgesics developer Vapogenix has received results of a Phase II clinical trial of its lead product, VPX638, which demonstrate rapid onset and sustained duration of pain relief and reduced opioid use for patients with painful wounds, the company said.

Analysis revealed that the patients experienced a significant decrease in pain for eight, 12 and even 24 hours after receiving VPX638.

The trial, which was conducted in Australia, did not achieve its primary endpoint, most likely due to study design issues.

However, in addition to the sustained reduction in pain, there was a substantial decrease in opioid use among the patients and no evidence of systemic or local adverse side effects.

In the Phase II trial, 50% fewer VPX638 patients required opioids for the 24 hours post-drug application.

The number of opioid free patients in that 24 hour period was 31% higher than in the control group, and there were no observed systemic side effects among patients who received VPX638.

In addition, patients receiving the medication experienced a decrease in opioid use during the night, suggesting a reduction in sleep interruption.

Giles said the encouraging data from the Phase II trial of VPX638 will inform the design of Phase IIb/III studies expected to begin in 2020 followed by a new drug application filing with the US Food and Drug Administration in 2022.

Vapogenix's portfolio of topical analgesics are novel, patented formulations of volatile anesthetics, which are currently unformulated and approved for use by inhalation for general anesthesia.

The company has formulated these VAs into topical gels and emulsions for localised treatment of pain associated not only with wounds, but also combat-related injuries, inflammatory conditions, and pain associated with common medical procedures, such as needle injections and more invasive procedures involving needle biopsies and cosmetic dermatology.

For children, ineffective procedural pain management is a serious problem and can have long-term negative effects.

In addition, Vapogenix's topical analgesics have anti-inflammatory and anti-microbial properties.

Vapogenix also announced it has retained Lighthouse BioPartners LLC to explore financing and strategic partnering opportunities to further develop Vapogenix' proprietary pipeline of non-opioid medications.

Vapogenix, based in Houston, Texas, is a clinical stage company developing a new class of topical, non-opioid analgesics to alleviate pain.

While most pain is localised, most pain medications are administered orally, which often results in systemic side effects. Vapogenix is focused on treating pain locally at its source.

The company's products are volatile anesthetics formulated for topical application.

VAs currently are unformulated and approved for use only as general anesthetics. Vapogenix has a robust intellectual property portfolio with 34 issued or allowed patents globally.