FDA Approves New Fentanyl Sublingual Spray

Susan Jeffrey

January 05, 2012

January 5, 2012 — Insys Therapeutics today announced that the US Food and Drug Administration (FDA) has granted approval for Subsys, a fentanyl sublingual spray for the treatment of breakthrough cancer pain.

The product is a sublingually administered formulation of fentanyl in a novel delivery device, a statement from the company notes. It is approved in cancer patients aged 18 years and older who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain, according to the release.

Breakthrough cancer pain occurs in approximately one third of patients treated for cancer, and in up to 80% of patients in later stages of disease.

"With the early onset of action, greater bioavailability, and broadest range of approved strengths, SUBSYS is poised to match the onset and intensity of a breakthrough cancer pain episode," Jeffrey A. Gudin, MD, from Englewood Hospital and Medical Center in New Jersey, said in the company's new release.

"Being a single-dose sublingual spray, we believe SUBSYS' unique and convenient delivery system will offer an important treatment option for appropriate patients," added Larry Dillaha, MD, chief medical officer of INSYS Therapeutics, in the release.

On December 29, 2011, the FDA approved a single, shared system risk evaluation and mitigation strategy (REMS) for the whole class of transmucosal immediate-release fentanyl (TIRF) drugs.

The shared system strategy, called the TIRF REMS Access Program, will replace individual REMS for these agents, allowing prescribers and pharmacies to enroll into a single system with the aim of "easing the burden on the health care system," a statement from the FDA noted.

Other TIRF opioid agents include brand-name drugs Abstral ([fentanyl] sublingual tablet; ProStrakan) and Actiq ([fentanyl citrate] oral transmucosal lozenge; Cephalon), and its generic equivalents Fentora ([fentanyl citrate] buccal tablet; Cephalon), Lazanda ([fentanyl] nasal spray; Archimedes Pharma), and Onsolis ([fentanyl] buccal; Meda Pharmaceuticals).

Prescribers and pharmacies already enrolled in an individual REMS program for at least 1 TIRF medication will automatically be transitioned to the shared TIRF REMS Access Program, the FDA notes.

To enroll, prescribers will be required to review the education program, successfully complete the knowledge assessment, and complete an enrollment form, according to FDA materials. Additional information about the enrollment process will be available on the TIRF REMS Access Program Web site when the program launches in March 2012.

In the manufacturer's statement, President and Chief Executive Officer Michael Babich noted that their new product will also fall under this new class of REMS.

"We intend to continue to grow our commercial organization and launch this product under the recently approved TIRF REMS Access Program when it is launched later this quarter," he said.


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