Spray Film Provides Alternative to Patches

Virpax Pharmaceuticals is developing a Patch-in-a-Can metered-dose spray film technology for topical drugs that it says will solve many of the drawbacks associated with other topical and transdermal drug delivery technologies. The technology uses a prefilled canister in a metered-dose aerosol spray device, similar to inhalation drug-delivery devices. Sprayed onto the skin, the API and a translucent polymer coating dry in approximately 1.5 minutes. The dose is clear, so it is more discrete than a patch, avoids the problem of patches that don’t stay in place, and is less messy than other topical forms, such as creams or gels, says the company. 

“The metered dosing of this technology allows timed release from 12 hours up to four days, which can match some of the existing timed-release patches,” comments Anthony P. Mack, CEO of Virpax. In addition, the spray form is economically more efficient compared to some patches that are overloaded and have some of the drug remaining in the discarded patch, says Mack.

The company plans to use the technology to deliver nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief, but it could also be used for other active ingredients, such as central nervous system drugs, notes Mack. 

In September 2018, Virpax Pharmaceuticals received guidance from FDA regarding its pre-investigational new drug (IND) application for its non-opioid therapy, DSF100 (1.3% diclofenac epolamine) spray, for acute pain due to minor strains, sprains, and contusions (1). FDA agreed that it is reasonable for Virpax to pursue a pursue a 505(b)(2) new drug application (NDA), which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a listed drug. Given this feedback, Virpax plans to finalize its IND application and prepare for a Phase I study of DSF100 in humans. Additionally, Virpax intends to submit a Canadian Clinical Trial Application. 

“We believe the advanced delivery system of DSF100 could provide an important tool in the management of acute pain without the use of opioid analgesics, which is a priority in today’s healthcare environment,” said Mack in the press release. “We are looking forward to moving ahead with our planned studies and executing on our clinical milestones in an accelerated manner through this regulatory pathway.”

Reference

1. Virpax, “Virpax Pharmaceuticals Reports Pre-IND Guidance From FDA for DSF100,” Press Release, Sept. 12, 2018.

Article Details

Pharmaceutical Technology
Vol. 42, No. 12
December 2018
Page: 42

Citation 

When referring to this article, please cite it as J. Markarian, "Spray Film Provides Alternative to Patches," Pharmaceutical Technology 42 (12) 2018.