FDA review gives Virpax go-ahead for pain relief candidates

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/M-gucci)
(Image: Getty/M-gucci)

Related tags: Virpax

A pre-IND review by the US FDA has allowed Virpax to continue with NDAs for DSF100 and LBL100, two pain relief products with specialised drug delivery formulations.

Last year, Virpax inked two licensing deals to gain access to proprietary drug delivery technology to administer non-opioid pain-relieving therapies.

The first agreement saw the company gain access to MedPharma’s ‘patch-in-a-can’ technology​, which is referred to as DSF100 within Virpax’s portfolio. The spray forms a film on the skin enabling the transdermal delivery of the nonsteroidal anti-inflammatory drug.

The second is a long-acting analgesic gel with a delivery method the company licensed from LipoCure​, which it has used to develop LBL100 to deliver 3% bupivacaine.

CEO of Virpax, Anthony Mack, told us that the company, after a pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration (FDA) regarding the two candidates, had been encouraged to apply for a new drug application (NDA).

Virpax’s applications arrive at a time when the FDA is looking to toughen the requirements​ for companies looking to bring forward new opioid treatments and the US Department of Defense provides funding​ for the development of non-opioid pain killers.

Mack explained why the transdermal delivery methods Virapax is exploring offers advantages over competing forms of delivery.

“Traditional patch formulations have to load their delivery systems with high volumes of active. In most situations, only a small amount of crosses the skin required for efficacy,” ​he explained. “Our metered dosed technology will spray on the amount required for therapeutic effect. Hence, the patient is getting the same amount of active.”

An added benefit of applying the pain relief directly onto the skin is that it removes the necessity to discard patches that still possess active ingredient, according to Mack.

The transdermal route also bypasses first-pass metabolism and allows for sustained pain relief – in the case of LBL100, allowing for postoperative analgesia effect of up to 96 hours.

Although the focus for Virpax is currently in pain relief, Mack told us that the delivery technology could potentially have applications for hormonal or central nervous system disorders.

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