There are four PDUFA dates the U.S. Food and Drug Administration (FDA) has scheduled for the rest of November to decide on drug approvals. Here’s a look.
Lipocine’s Tlando as Testosterone Replacement Therapy
Lipocine, based in Salt Lake City, Utah, has a target action date of November 9, 2019 for its New Drug Application (NDA) for Tlando as testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, which is also called hypogonadism. Tlando is designed to be a fixed dose oral TRT.
The company notes that in 2018, about 7.2 million prescriptions were written for non-oral TRT. A non-invasive oral TRT has benefits over topical formulations because there is no risk of accidental testosterone transference.
Ocular Therapeutix’ Dextenza for Ocular Inflammation After Eye Surgery
Bedford, Massachusetts-based Ocular Therapeutix has a target action date of November 10 for its supplemental NDA for Dextenza (dexamethasone ophthalmic insert) to include ocular inflammation following ophthalmic surgery in its label. Dextenza was approved by the FDA as an intracanalicular insert delivering dexamethasone for post-surgical ocular pain for up to 30 days with a single dose. Dextenza is a resorbable, preservative-free ophthalmic insert placed in the lower lacrimal punctum and into the canaliculus of the eye.
The sNDA is based on two Phase III trials in cataract surgery patients that showed statistical significance compared to the vehicle control for absence of ocular pain and absence of inflammation.
On October 1, Dextenza was granted a permanent J-code (J1096) by the Healthcare Common Procedure Coding System (HCPCS), replacing the previously issued C-code (C9048). J-codes are a subset of HCPCS Level II codes used to primarily identify injectable drugs.
Agile Therapeutics’ Twirla Contraceptive Patch
Princeton, New Jersey-based Agile Therapeutics has a target action date of November 16 for its NDA resubmission for Twirla (AG200-15), an investigational low-dose combined hormonal contraceptive patch. The company received a Complete Response Letter (CRL) from the FDA in December 2017. The CRL noted quality control adhesion test method deficiencies, problems with a third-party manufacturer, and issues with the in vivo adhesion properties of Twirla and the SECURE clinical trial.
The resubmitted NDA included data from a comparative wear study conducted at the request of the FDA, more information on the manufacturing process and additional analyses.
On October 30, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) met to discuss the NDA and voted 14 to one, with one abstention, that the benefits of Twirla outweigh the risks to support approval.
Aquestive Therapeutics’ Exservan for ALS
Aquestive Therapeutics, based in Warren, New Jersey, has a target action date of November 30 for its NDA for Exservan (riluzole oral film (ROF)) for amyotrophic lateral sclerosis (ALS). The product received FDA orphan drug designation in January 2018. The company’s focus is to collaborate with pharma partners to bring new molecules to market using its proprietary, best-in-class technologies, such as PharmFilm.
PharmFilm allows for sublingual, lingual or buccal drug delivery. It requires no mixing, swallowing or chewing.
“We are pleased the FDA has accepted our NDA for Exservan, given the needs ALS patients have for treatment advances,” said Daniel Barber, Aquestive’s chief strategy and development officer, in April when the FDA accepted the NDA. “ALS, though relatively rare, represents a considerable economic and social burden in the U.S. and globally. Oral films offer great promise to patients who face difficulty swallowing or administering traditional forms of medication.”
