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 Labs owns the exclusive U.S. and specified international commercialization rights to Sildenafil Oral Spray under a licensing agreement with Farmalíder S.A. (Madrid, Spain), a leader in the Spanish OTC and ibuprofen market.

Market Exclusivity + IP Protection

Pathway To Approval

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

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Investment Highlights

01

Differentiated Delivery

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)

02

Proven Technology

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.

03

Market Exclusivity & Patent Protected

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.

04

De-Risked Development

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

05

Market Opportunity

Unique opportunity for investors to participate in the growing erectile dysfunction market, expected to reach $7.1B worldwide by 2024

Dosage

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.

Proven Technology

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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Use In Simultaneous And Other Indications

Dysphagia, Pulmonary Arterial Hypertension (PAH), Persistent Pulmonary Hypertension (PPHN) and Scleroderma

Sildenafil has been recognized to have applications as a therapeutic treatment for several indications, including Pulmonary Arterial Hypertension (PAH), Persistent Pulmonary Hypertension (PPHN) and scleroderma, and is especially advantageous for ED patients suffering from dysphagia. LEARN MORE