FDA Action Alert: Theravance's Approval, Mallinckrodt and Aquestive

FDA lettering on stamp with red background

The Food and Drug Administration (FDA) is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for chronic obstructive pulmonary disease, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.

Theravance’s Revefenacin for COPD

Theravance Biopharma, based in Dublin, Hertfordshire, England, and Pittsburgh, along with Mylan, have a target action date of November 13 for their New Drug Application (NDA) for Yupelri (revefenacin). The drug is a long-acting muscarinic antagonist (LAMA) being evaluated for chronic obstructive pulmonary disease (COPD).

The agency indicated it didn’t plan on holding an advisory committee hearing about the NDA. 

At the company’s third-quarter financial report on November 6, Rick E. Winningham, company chairman and chief executive officer, noted that the company had recently sold its Vibativ to Cumberland Pharmaceuticals, which “allows our commercial organization to concentrate exclusively on the potential launch of Yupelri, which if approved will be the first once-daily nebulized LAMA for the treatment of COPD.”

The FDA jumped ahead and approved the drug on Friday, November 9.

FDA Adcom to Meet on Mallinckrodt’s Roxicodone

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will have a joint meeting on November 14. The two committees will evaluate the 505(b)2 new drug application submission for Mallinckrodt Pharmaceuticals' MNK-812, the company’s abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic. 

The target action date for the drug is November 16. “We look forward to engaging with the Advisory Committees to discuss the potential benefits our new abuse-deterrent formulation technology can bring in helping to mitigate opioid abuse and misuse,” stated Matt Harbaugh, Mallinckrodt's executive vice president, chief financial officer and president of Specialty Generics in October.

Aquestive Therapeutics’s AQST-119 for Erectile Dysfunction

Aquestive Therapeutics (Formerly known as MonoSolRx), headquartered in Warren, New Jersey, has a target action date of November 18 for its AQST-119, an oral film formulation of tadalafil, for erectile dysfunction. The company focuses on developing and delivering medications by way of its PharmFilm technology, which allows patients to take medications by placing the film under their tongue.

Tadalafil is a PD35 inhibitor marketed by Eli Lilly and Company as Cialis for erectile dysfunction and for treatment of pulmonary arterial hypertension under the name Adcirca.

At the company’s third-quarter financial statement on November 6, Keith J. Kendall, company chief executive officer, emphasized the commercial launch of a compound from its central nervous system franchise, rather than the upcoming tadalafil formulation. “Aquestive is the worldwide leader in delivering therapeutics on oral film with our PharmFilm technology. Over the past quarter, we have met a number of key business milestones that position us well to achieve our long-term vision for growth. We are excited to continue advancing our pipeline and building our CNS commercial franchise with the launch of Sympazan. Late stage development of Libervant is also advancing with the recent completion of the adult EMU study.”

Sympazan’s oral film was approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years or older.

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