Karma Biosciences, a Corvallis, Oregon-based biotechnology company, announced on May 8, 2025, that it has filed patent applications for two novel nasally-administered PDE-5 inhibitor formulations. The company has developed nasal versions of sildenafil (Viagra) and vardenafil (Levitra) using its proprietary Zenergy™ excipient technology.
According to the company, in-vivo testing has demonstrated significant advantages over existing oral formulations. "Our studies have shown that compared to the available oral formulations of these drugs, our nasally administered sildenafil and vardenafil formulations have significantly faster onset, within 5 minutes of administration, and significantly higher peak blood levels than any other available products," said Charles Bentz, MD, Chief Medical Officer at Karma Biosciences.
Innovative Drug Delivery Technology
The company's Zenergy™ excipient forms a carrier vehicle around drug particles, facilitating rapid penetration of phospholipid membranes within the nasal cavity. This mechanism enables drugs to enter the bloodstream more rapidly and achieve higher concentrations compared to oral or quick-dissolve formulations.
This technology platform could potentially transform drug delivery beyond PDE-5 inhibitors. According to Karma Biosciences, the Zenergy™ excipient allows for nasal administration of medications that would typically require injection, potentially improving patient convenience and compliance.
Market Potential and Clinical Applications
PDE-5 inhibitors are primarily known for treating erectile dysfunction, helping men achieve and maintain erections. However, these medications have additional medical applications, including treatment of pulmonary arterial hypertension.
The global erectile dysfunction market is currently valued at approximately $3 billion and growing at an annual rate of 9%. This growth is partly driven by expanding telehealth services and direct-to-consumer channels worldwide, which have increased access to these medications.
"We believe that these PDE-5 inhibitor formulations will have huge impact on the market," said Glen Cunningham, CEO of Karma Biosciences. "As patients continue to search for the fastest, most effective drugs to achieve their health goals, Karma will continue to develop novel solutions."
Business Development Strategy
Karma Biosciences has previously utilized its Zenergy™ excipient in various other drug formulations with positive results. The company is currently developing additional novel drug products using this platform technology.
The company is actively seeking partnerships to license or co-develop these products for distribution. "We are excited to partner with other forward-thinking companies to introduce these and other products to market," Cunningham stated.
This development represents a potential advancement in PDE-5 inhibitor therapy, offering patients a faster-acting alternative to traditional oral medications. If approved, these nasal formulations could provide significant advantages in onset of action and bioavailability, potentially addressing unmet needs in the current treatment landscape.
