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 tablet medications, such as VIAGRA® and Cialis® 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 regulation provides that new routes of administration for a previously approved drug qualify for an expedited form of approval.
Aspargo is seeking to obtain regulatory authorization to market Sildenafil Oral Spray in Germany and various European countries under the “decentralized procedure”, whereby a marketing authorization granted in one “Member State” (the “Reference Member State”) can be recognized simultaneously in other EU countries (the “Concerned Member States”).
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 the need to crush pills prior to administration; and readily available and convenient administration for ED patients suffering from dysphagia (trouble swallowing).
Sildenafil Oral Spray is approved for sale in Spain and is undergoing registration in France and Italy.
Aspargo owns the exclusive rights to manufacture and market Sildenafil Oral Spray in the United States and more than 30 countries throughout Europe, Russia, Asia, the Middle East, South America, the United Kingdom and Canada. Aspargo owns the exclusive rights for those jurisdictions to granted United States, European and Russian patents covering the proprietary liquid and spray formulations.
The FDA has reviewed Aspargo’s drug approval plan for Sildenafil Oral Spray and confirmed the availability of the 505(b)(2) pathway for approval. This pathway eliminates the need for protracted patient studies and relies on safety and efficacy data generated previously by Pfizer for VIAGRA®.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has approved Sildenafil Oral Spray for sale in Spain; Aspargo’s route to approval in Germany and across Europe does not require additional studies; the “decentralized procedure”, whereby a marketing authorization granted in one “Member State” can be recognized in other EU countries, provides a straightforward path to approval.
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 into the mouth 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.
Currently, Sildenafil Oral Spray is prescribed by physicians to treat erectile dysfunction as an alternative to VIAGRA® and Cialis® tablets in Spain and is undergoing registration in Italy and France. Read More
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Aspargo Laboratories, Inc. is a clinical-stage biopharmaceutical company developing patient-focused solutions and must-have medicines by combining our innovative science and technologies with FDA’s 505(b)(2) approval pathway and corresponding regulations in international jurisdictions to enhance currently marketed drugs with well-known pharmacology profiles.