Managing Erectile Dysfunction with a Novel Delivery System for a Proven Drug
Aspargo’s oral spray suspension formulation of sildenafil citrate (Sildenafil Oral Spray), the active ingredient in VIAGRA®, is a novel and convenient route of administration for this commonly prescribed medication for erectile dysfunction. Aspargo’s unique oral spray formulation is designed to offer patients an alternative to VIAGRA® and Cialis® tablets and their respective generic equivalents.
Aspargo is seeking to obtain FDA authorization to market Sildenafil Oral Spray in the United States pursuant to the approval pathway described in section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. This FDA regulation provides that new routes of administration for a previously approved drug qualify for an expedited form of approval. LEARN MORE
Sildenafil Oral Spray is designed to offer patients: convenient oral drug administration without the need for accompanying liquids; flexible-dose titration in increments of 12.5 mg to deliver maximum benefits without adverse side effects; and administration without need to disintegrate tablets prior to dosing for those suffering from dysphagia (trouble swallowing)
The oral suspension formulation of sildenafil citrate is approved for sale in 9 European countries in a liquid dosage form and in Spain in the spray dosage form; the spray dosage form is undergoing registration in 40 jurisdictions worldwide, including 8 European countries and 8 Latin American countries.
Aspargo owns the exclusive rights to manufacture and market Sildenafil Oral Spray in the United States and the exclusive rights to a granted United States patent covering the proprietary liquid and spray formulations.
The FDA has confirmed to Aspargo that Sildenafil Oral Spray is eligible for FDA approval under the 505 b(2) regulatory approval pathway for new formulations of previously approved drugs; Aspargo’s route to approval requires a small, low-risk clinical trial with reduced cost and timeline compared to the traditional clinical trials required for FDA approval of new drugs
Unique opportunity for investors to participate in the growing erectile dysfunction market, expected to reach $7.1B worldwide by 2024
Sildenafil Oral Spray is dispensed from a metered dose pump that delivers exactly 12.5 mg per push of the pump. Patients will administer a physician prescribed number of metered sprays onto or under the tongue when needed prior to sexual activity. Two sprays are equivalent to a 25 mg VIAGRA® tablet; four sprays are equivalent to a 50 mg VIAGRA® tablet and eight sprays are equivalent to a 100 mg VIAGRA® tablet.
Sildenafil Oral Spray is prescribed by physicians to treat erectile dysfunction as an alternative to VIAGRA® tablets in Spain and will soon be available in other countries throughout Europe. Read More
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Aspargo Laboratories, Inc. is a clinical-stage biopharmaceutical company developing patient-focused solutions and must-have medicines by applying our innovative science and technologies and FDA’s 505(b)(2) approval pathway to enhance currently marketed drugs with well-known pharmacology profiles.