FDA Action Alerts: Lannett, Indivior, Insys and Progenics

July can be a notoriously slow period for U.S. Food and Drug Administration (FDA) activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda for adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. The PDUFA date was July 3, but it was approved June 13. At this point in the month, there are only four more approvals on the docket, although August looks to be a very busy month to make up for it. Here are the remaining approvals scheduled for July.

Lannett’s Cocaine Hydrochloride Topical Solution

The FDA’s PDUFA date for Lannett’s Cocaine Hydrochloride Topical Solution, with a proposed trade name of Numbrino is July 21, 2018. The New Drug Application (NDA) for the Philadelphia-based company was accepted for standard review on December 1, 2017. The drug is to be used as a local topical anesthetic.

“The FDA’s acceptance of the Cocaine HCL Topical Solution NDA is an important step in the FDA review process, indicating that the application is sufficiently complete to permit a substantive review,” said Arthur Bedrosian, Lannett’s chief executive officer, in a December statement. “Cocaine Hydrochloride Topical Solution represents an opportunity to bring a new local anesthetic to the medical community and patients. We are currently seeking an approval for the product with a nasal indication and, once approved, plan to pursue additional indications.”

DURECT and Indivior’s Risperidone for Schizophrenia

The FDA has a target action date of July 28, 2018, for DURECT Corporation and Indivior’s RBP-7000, a once-monthly injectable risperidone for schizophrenia. On September 26, 2017, DURECT inked a patent purchase deal with Indivior UK Limited for RBP-7000. Indivior made an upfront non-refundable payment to DURECT of $12.5 million and agreed to an additional $5 million contingent upon NDA approval, with quarterly earn-out payments based on a single digit percentage of U.S. net sales after approval.

Insys Therapeutics’ Buprenorphine Spray for Pain

The FDA’s PDUFA date for Insys’ novel formulation of buprenorphine as a sublingual spray for moderate-to-severe acute pain is also July 28, 2018. As part of the company’s NDA, the company had completed a seven-day safety and tolerability study on 100 patients, which was submitted in the first quarter of 2018. This could potentially push the PDUFA date back.

“We look forward to working with the FDA in 2018 to add our buprenorphine sublingual spray to the range of treatment options available to physicians whose patients suffer from moderate-to-severe acute pain,” said Steve Sherman, Insys’s senior vice president of regulatory affairs in a December 2017 statement. “We believe that this novel formulation and delivery method of buprenorphine holds great promise as an alternative to traditional opioids.”

On May 22, an advisory committee voted not to recommend approval of the NDA. That’s not a binding recommendation, but Adcom recommendations are usually followed. In a statement on that date, Sherman said, “We appreciate the panelists’ perspective and guidance. Believing that our sublingual delivery technology could contribute significantly to bring value to patients, we will continue to work with the FDA in the coming months to discuss the path forward for our buprenorphine product candidate and to build on the current body of evidence for its efficacy and safety.”

Progenics Pharma’s Azedra for Malignant Pheochromocytoma and Paraganglioma

On March 22, 2018, Progenics Pharmaceuticals indicated that the FDA was extending its review of its NDA for Azedra (iobenguane I 131) by three months to July 30, 2018. This was because of a submission of additional Chemistry, Manufacturing, and Controls (CMC) information by the company, which the agency needed more time to review.

“We remain confident in our NDA submission and are committed to bringing Azedra forward as an option for patients with malignant pheo and para,” said Mark Baker, Progenics’ chief executive officer, in a March SEC filing. “We look forward to continuing our dialogue with the Agency as we prepare for a potential approval of Azedra.”