HOUSTON–(BUSINESS WIRE)– October 29, 2019 Vapogenix, a clinical-stage firm growing a brand new class of topical non-opioid, lidocaine-free analgesics, at present introduced outcomes of a Part II medical trial of its lead product, VPX638, which show speedy onset and sustained length of ache aid and diminished opioid use for sufferers with painful wounds.
Evaluation revealed that the sufferers skilled a major lower in ache for 8, 12 and even 24 hours after receiving VPX638. The trial, which was performed in Australia, didn’t obtain its main endpoint, most probably as a result of examine design points. Nevertheless, along with the sustained discount in ache, there was a considerable lower in opioid use among the many sufferers and no proof of systemic or native opposed unintended effects.
“The information strongly means that this novel class of non-opioid analgesics has the potential to offer substantial ache aid for sufferers with all kinds of wounds, together with diabetic foot ulcers and venous ulcers, burns and non-healing traumatic and post-surgical wounds,” mentioned Vapogenix CEO Heather Giles, Ph.D.
“The nationwide opioid epidemic mixed with the persevering with medical want for ache aid creates an pressing demand for Vapogenix’s pipeline of non-opioid analgesics,” Giles added. “There’s a compelling want for brand spanking new ache medicines which might be opioid sparing and are protected with no systemic unintended effects.”
Within the Part II trial, 50% fewer VPX638 sufferers required opioids for the 24 hours post-drug utility. The variety of opioid free sufferers in that 24 hour interval was 31% greater than within the management group, and there have been no noticed systemic unintended effects amongst sufferers who acquired VPX638. As well as, sufferers receiving the treatment skilled a lower in opioid use in the course of the night time, suggesting a discount in sleep interruption.
“The general constructive knowledge coupled with the necessity for non-opioid ache medicines clearly warrant additional examine and growth of VPX638,” mentioned Prof. Michael Woodward, M.D., of the College of Melbourne and Previous President of the Australian Wound Administration Affiliation. “Wound ache is a big downside and to have an analgesic that may scale back the necessity for narcotic prescriptions could be a real breakthrough.”
Pat Aldons, MBBS, FRACP, Senior Visiting Advisor Doctor at The Prince Charles Hospital in Brisbane, added, “Ache is usually the worst symptom related to wounds and it will possibly delay a affected person’s restoration. A topical analgesic with an extended length of motion could be a very vital advance.”
Giles mentioned the encouraging knowledge from the Part II trial of VPX638 will inform the design of Part IIb/III research anticipated to start in 2020 adopted by a brand new drug utility (NDA) submitting with the U.S. Meals and Drug Administration in 2022.
Vapogenix’s portfolio of topical analgesics are novel, patented formulations of unstable anesthetics (VAs), that are presently unformulated and permitted to be used by inhalation for common anesthesia.
The corporate has formulated these VAs into topical gels and emulsions for localized remedy of ache related not solely with wounds, but additionally combat-related accidents, inflammatory circumstances, and ache related to frequent medical procedures, corresponding to needle injections and extra invasive procedures involving needle biopsies and beauty dermatology. For kids, ineffective procedural ache administration is a major problem and might have long-term unfavorable results. As well as, Vapogenix’s topical analgesics have anti-inflammatory and anti-microbial properties.
Vapogenix additionally introduced it has retained Lighthouse BioPartners LLC () to discover financing and strategic partnering alternatives to additional develop Vapogenix’ proprietary pipeline of non-opioid medicines.
Vapogenix, based mostly in Houston, TX, is a medical stage firm growing a brand new class of topical, non-opioid analgesics to alleviate ache. Whereas most ache is localized, most ache medicines are administered orally, which frequently leads to systemic unintended effects. Vapogenix is concentrated on treating ache regionally – at its supply. The Firm’s merchandise are unstable anesthetics (VAs) formulated for topical utility. VAs presently are unformulated and permitted to be used solely as common anesthetics. Vapogenix has a strong mental property portfolio with 34 issued or allowed patents globally. To study extra about Vapogenix, go to
Posted: October 2019