Aspargo Labs Inc.
Sildenafil Oral Spray
Manufacturing and Packaging
Aspargo is collaborating with Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization located in Hunt Valley, MD to develop and manufacture Sildenafil Oral Spray for clinical trials. Pii is also laying the groundwork for the future commercial manufacturing requirements of Sildenafil Oral Spray.
Market Strategy
We seek to quickly capture market share with this novel formulation of sildenafil citrate. We intend to aggressively market Sildenafil Oral Spray and build awareness among key opinion leaders and healthcare professionals, enabling us to build brand loyalty and to continually expand our market share. As the market matures, we intend to maintain our market position by leveraging our brand equity and name recognition in the market. We aim to win market dominance through product innovation and product line extensions. Our branding will enable us to develop trust and a deep emotional connection with patients.
Benefits of a 505(b)(2) pathway include the opportunity to:
- Eliminate the need to duplicate studies to demonstrate what is already known about sildenafil citrate in the treatment of ED.
- Obtain FDA approval based on a single low-risk trial in a small number of healthy volunteers.
Aspargo is seeking to file its New Drug Application (NDA) in Q1 2022 and obtain FDA approval and commercially launch the product in Q1 2023.
Aspargo’s Sildenafil Oral Spray is protected by US patent No. 10,016,428 B2 (granted: July 10, 2018) – Pharmaceutical Composition of Sildenafil Citrate in the Form of a Suspension for Oral Use – and by trade secrets and manufacturing know-how necessary to manufacture the oral spray formulation and to ensure drug stability. Aspargo is protecting its custom designed spray bottle with US and international patent applications.
Aspargo is partnering with Syneos Health to develop a global commercialization plan with multi-channel programs designed to ensure Sildenafil Oral Spray launch success.
Sildenafil spray is manufactured and packaged on behalf of Farmalider by Edefarm Laboratorios, a contract manufacturer of pharmaceuticals located in Valencia, Spain.
Edefarm has transferred all manufacturing technology, analytical methods and know-how to Pii.
Pii has confirmed and augmented the analytical methods developed by Farmalider and Edefarm, is conducting the required stability studies on the drug product and is manufacturing the clinical supplies and commercial batches needed for our clinical study and FDA submissions.
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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.