FDA plans upcoming adcomms for OTC contraceptive, epinephrine nasal spray, Intarcia’s last shot

The FDA has scheduled or planned for three advisory committee meetings in May: one for an over-the-counter birth control pill, one for a nasal spray version of the EpiPen, and another for  Intarcia Therapeutics, which has all but completely folded already as a company.

Perrigo will bring its daily contraceptive, Opill, to the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on May 9 and 10 for its over-the-counter birth control application.

Perrigo’s affiliate HRA Pharma filed an application with the FDA back in July. The company says if it’s approved, it will be the first daily birth control pill available over the counter without a prescription in the US. HRA’s progestin-only pill Hana is already approved for over-the-counter use in Britain.

The FDA delayed Opill’s adcomm last year, which was originally supposed to take place in November, “to review additional information requested related to the Opill® Rx-to-OTC switch,” Perrigo said in a statement.

According to HRA, the pill was approved by the FDA in 1973.

Namandjé Bumpus

Meanwhile, battered Intarcia Therapeutics was also granted an adcomm instead of a formal evidentiary hearing, according to a letter from FDA chief scientist Namandjé Bumpus. In February, Intarcia submitted a citizen petition for an alternative form of hearing. Bumpus wrote that she would meet with the company as well as the Center for Drug Evaluation and Research (CDER) to talk about the format for the hearing.

“In terms of the process for the advisory committee hearing itself, I plan to refer the matter to CDER to conduct the hearing consistent with its typical process,” Bumpus added.

The letter does not specify what the adcomm for Intarcia will be about, but by August of last year the company’s leaders had left and the FDA had denied Intarcia’s request for a hearing to review the company’s twice-rejected type 2 diabetes drug candidate and proprietary delivery system. At the time of the FDA’s denial, the agency cited device and product quality issues and clinical deficiencies.

“The FDA does not always convene an Advisory Committee Meeting in connection with application reviews but may do so when questions related to safety or the data submitted to support approval arise,” a representative for the FDA told Endpoints News in response to a question for more information.

In addition, the FDA scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting on May 11 to review an epinephrine nasal spray, known as neffy, and submitted by ARS Pharmaceuticals Inc., for the proposed indication of emergency treatment of allergic reactions including anaphylaxis in adults and children larger than 30 kilograms (66 pounds).

Dubbed by ARS as the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions, the company said in a comment that FDA told them:

1. “An Advisory Committee is an important aspect of the review given the new route of administration for an emergency use product that has clinical efficacy trial feasibility issues.
2. Additional experts with knowledge in systemic allergic reactions and anaphylaxis will be invited to participate in the Advisory Committee.
3. The FDA would not be planning to bring ARS’s application to an Advisory Committee if they did not feel the PK/PD provided by ARS had the potential for approval.”

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