Aspargo Labs Unveils Data: ASP-001 Oral Spray Absorbs Twice as Fast as Viagra®

Aspargo Labs, Inc., a specialty pharmaceutical and MedTech company, has announced the promising results of a Phase 1 study for ASP-001, an innovative sildenafil oral spray developed for erectile dysfunction (ED). The study, published in the International Journal of Science and Research (IJSR), reveals that ASP-001 achieves absorption within five minutes, which is twice as fast as traditional sildenafil tablets.

ASP-001 uses sildenafil, the active ingredient in Viagra®, and has already secured regulatory approval in countries including Spain, Germany, the Netherlands, Ireland, Mexico, and the United Kingdom. The company is now seeking its first U.S. Food and Drug Administration (FDA) approval for ASP-001 while exploring oral suspensions and solutions for other medications currently only available in tablet form.

Aspargo Labs' oral spray formulation offers a discreet and spontaneous alternative to traditional tablets. The company's oral suspension technology aims to overcome challenges associated with pills, such as slower absorption rates and the need for fasting or food intake before use. The spray's convenient application method also eliminates the need for additional liquids. By enhancing ease of use and flexibility, Aspargo Labs’ technology provides a patient-centric approach to improving medication efficacy, adherence, and safety.

Michael Demurjian, CEO of Aspargo Labs, emphasized that their innovative oral spray technology simplifies drug administration. "The study data supports the safety and pharmacokinetic profile of our oral spray. Our research shows that ASP-001 is absorbed more rapidly than Viagra® tablets in the initial minutes after use. We are eager to collaborate with the FDA to file an NDA for ASP-001 for ED treatment and look forward to making this drug available to patients in the U.S.," Demurjian said.

The IJSR study was authored by Dr. Steven Kaplan, Chief Medical Officer at Aspargo Labs and Director of the Men’s Wellness Program at Mount Sinai Health System. "The rapid absorption profile of ASP-001 in this Phase 1 study addresses key unmet needs in ED treatment," noted Dr. Kaplan. "Many patients find it inconvenient to plan ahead for taking a tablet. An oral spray that achieves therapeutic levels quickly could be a significant advancement. If approved, ASP-001 could offer a practical option for enhancing sexual health and overall quality of life."

The open-label, single-center, two-way crossover study analyzed the pharmacokinetics of 4 ml of ASP-001 versus 100 mg Viagra® in 53 healthy, fasted male volunteers. The study measured absorption rate, safety, and tolerability. Participants were selected after a 28-day screening and were randomized for dosing after a 10-hour fasting period. A total of 24 plasma blood samples were collected over 24 hours.

Key study findings include:
- Initial absorption was noted within 5 minutes of administration, with ASP-001 showing a higher average concentration in the bloodstream (0.615 ng/mL) compared to Viagra® tablets (0 ng/mL).
- Average bloodstream levels via mean plasma concentrations were higher for ASP-001 compared to Viagra® tablets in the first 30 minutes post-administration.

The company is pursuing additional regulatory submissions to support approvals in key global markets, including Japan, the Middle East, and South America.

Aspargo Labs, Inc. is focused on transforming drug delivery with oral sprays. Their technology aims to convert solid dose medications into easy-to-administer sprays, offering advantages like enhanced drug delivery, patient-centricity, dosing flexibility, and personalized medicine. Aspargo is the U.S. and international licensee of the patent rights for Sildenafil Spray from Farmalider, S.A. of Madrid, Spain.

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