Aquestive Therapeutics Inc (NASDAQ:AQST) just hit the wires on late Friday with the announcement that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF).

According to the release, Tadalafil is a PDE5 inhibitor currently marketed in tablet form for the treatment of erectile dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis, and for treatment of pulmonary arterial hypertension under the brand name Adcirca. In the letter, the FDA requested limited additional data from healthy volunteers. The company has also notified the agency about its plans to engage an alternative supplier of the active pharmaceutical ingredient (API).

Aquestive Therapeutics Inc (NASDAQ:AQST) promulgates itself as a specialty pharmaceutical company that focuses on identifying, developing, and commercializing various products to address unmet medical needs. Its products are developed using its PharmFilm technology.

The company’s marketed products include Suboxone, a sublingual film formulation of buprenorphine and naloxone for the treatment of opioid dependence; and Zuplenz, an oral soluble film formulation of ondansetron antagonist for the treatment of nausea and vomiting associated with chemotherapy and post-operative recovery.

Its proprietary product candidates that are in development comprise AQST-203, a buccally, an administered soluble film formulation of diazepam for the treatment of recurrent epileptic seizures; AQST-120, an oral soluble film formulation of clobazam for the treatment of seizures associated with a rare, intractable form of epilepsy; and AQST-117, an oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis.

The company’s development products also include AQST-108, a sublingual film formulation of epinephrine for the treatment of anaphylaxis; AQST-305, a buccal film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors; APL-130277, a sublingual film formulation of apomorphine to treat episodic off-periods in Parkinson’s disease; AQST-119, an oral soluble film formulation of tadalafil to treat erectile dysfunction; and AQST-306, a film formulation of edaravone.

Aquestive Therapeutics, Inc. was founded in 2004 and is headquartered in Warren, New Jersey.

 

It’s Not Going to be Pretty

We started off by noting that AQST recently hit the wires with the announcement it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF).

“The matters cited in the CRL are unique to the oral film formulation of tadalafil, and do not affect any other products that Aquestive develops, markets or manufactures. The comments provided in the CRL are manageable and we will work with the FDA to map out our path to resubmission and approval,” said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. “We continue to see a pathway to tentative approval before the expiry of the patents for the reference product. We anticipate partnering tadalafil OF once approved and the CRL has not changed our timing or intent.”

Nonetheless, one expects a difficult open for the stock on Monday. It is rare to see this type of situation turn out in any other way.

Aquestive Therapeutics Inc (NASDAQ:AQST) generated sales of $13.3M, according to information released in the company’s most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of -4.7% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($64M against $21.3M).

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