Alignment with FDA to pursue 505(b)(2) regulatory pathwayOn-track for IND filing in Q3 2020
ENGLEWOOD CLIFFS, N.J., May 04, 2020 (GLOBE NEWSWIRE) -- Aspargo Laboratories, Inc. (Aspargo), a privately held, clinical stage pharmaceutical company, today announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed Aspargo's questions and provided guidance on the Company’s Sildenafil Oral Spray for the treatment of erectile dysfunction (ED).
A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the Agency’s guidance for clinical studies for the sponsor’s new drug candidate. The FDA was supportive of a single dose bioequivalent study comparing Aspargo’s Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra® tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.
“We are encouraged by the outcome of the pre-IND meeting with the FDA and based on their feedback are advancing towards an IND submission for Sildenafil Oral Spray in the third quarter of 2020,” said Michael Demurjian, Chief Executive Officer of Aspargo. “Importantly, the FDA deemed the 505(b)(2) regulatory pathway appropriate for our clinical program and pending results from our planned single-dose bioequivalent study, we do not foresee the need to conduct any additional long-term safety, toxicology or phase 3 efficacy studies. We look forward to advancing Sildenafil Oral Spray in the U.S. market to provide men who suffer from erectile dysfunction a differentiated dosing formulation that provides convenient administration, flexible dosing and access for ED patients who have difficulty swallowing oral tablets.”
In its written response, the FDA supported Aspargo’s plan to conduct a single dose bioequivalent study to evaluate the pharmacokinetics, bioequivalency, tolerability and safety of the Company’s Sildenafil Oral Spray drug candidate, administered via a metered dose pump or individual single liquid unit, when compared to Viagra® tablets. The randomized, single center, unblinded, three-way crossover study will seek to enroll a total of 72 healthy volunteers who will receive a single dose of Sildenafil Oral Spray administered via a dose metered pump, a single dose of Sildenafil Oral Spray administered via an individual single liquid unit or a single dose of Viagra® oral tablet. Thirty-six subjects will be treated under fed conditions and thirty-six subjects will be treated under fasting conditions.
The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of clinical trials.
Aspargo is collaborating with Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization located in Hunt Valley, MD (www.pharm-int.com) 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 in the U.S.
About Erectile Dysfunction (ED)
Erectile dysfunction (ED), also known as impotence, is a type of sexual dysfunction characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. Common causes of ED include: heart disease; clogged blood vessels (atherosclerosis); high cholesterol; high blood pressure; diabetes; obesity; metabolic syndrome; Parkinson’s disease; Multiple Sclerosis; certain prescription medications; tobacco use; Peyronie's disease; alcoholism and other forms of substance abuse; sleep disorders; treatments for prostate cancer or enlarged prostate; surgeries or injuries that affect the pelvic area or spinal cord; and low testosterone. Psychological conditions, such as stress, anxiety or depression, can contribute to erectile dysfunction.
About Aspargo’s Sildenafil Oral Spray
Aspargo’s Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5 mg of sildenafil per push of the pump (referred to as ASP-001) or via an individual single liquid unit dispensing 100 mg per unit (referred to as ASP-002). The oral spray liquid suspension is currently approved for sale in Spain, Portugal, Italy, Poland, The Czech Republic, Slovakia, Hungary, Romania, Bulgaria and Greece. Regulatory approval is pending in Brazil, China, France, Germany, Israel, Mexico, Ukraine and the United Kingdom.
About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a clinical stage pharmaceutical company focused on developing an oral spray formulation of sildenafil, the active ingredient in Viagra®, in the United States. Aspargo is the exclusive U.S. licensee of the U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. of Madrid, Spain (www.farmalider.com).
Aspargo’s leadership team has a proven background and a track record in successful drug product development, regulatory approval and commercialization. For additional information, please visit our website at www.aspargolabs.com.
Forward Looking Statements
This press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events, they give no assurance that such expectations will prove to be correct. Forward-looking statements are subject to a number of risks and uncertainties, but not limited to, our liability to obtain additional capital on acceptable terms, or at all, including additional capital which will be necessary to complete the clinical trials, delays caused by institutional review boards or regulatory agencies, enrollments, shortage of clinical trial supplies, dependence on clinical trial collaborators, loss of any executive officers or key personnel or consultants. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Aspargo disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Aspargo Laboratories, Inc.