FDA Action Alert: Satsuma, Theratechnologies and Heron

FDA_iStock, JHVEPhoto

Pictured: A sign at FDA headquarters/iStock, JHVEPhoto

The FDA is looking at three target action dates over the next two weeks, including one for a nasal powder migraine treatment and another being proposed to treat excess abdominal fat in adults living with HIV who have lipodystrophy.

Read below for more.

Satsuma Awaits Decision for Nasal Powder Treatment for Migraine

Satsuma Pharmaceuticals is developing a dihydroergotamine (DHE) nasal powder product dubbed STS101, which it is proposing for the treatment of acute migraine. The deadline for the FDA’s decision is January 17. 

STS101’s New Drug Application (NDA), which the regulator accepted in May 2023, is backed by data from the Phase III ASCEND study, which enrolled 446 patients treated with over 10,500 doses of STS101 for up to 18 months.

In September 2022, Satsuma posted positive long-term data from ASCEND, showing that the drug could elicit freedom from pain within two hours of treatment in at least 34% of patients. STS101 was also safe in the long run, with no clinically relevant nasal or systemic safety issues. Most treatment-emergent adverse events were mild or moderate and transient. STS101’s NDA also includes data from a Phase I comparative pharmacokinetic and safety study.

If approved, STS101 would become the first DHE product tested in a randomized and placebo-controlled trial using modern outcome measures, as recommended by the FDA and the International Headache Society, according to Satsuma’s announcement of the NDA’s acceptance.

Theratechnologies Eyes Approval for New Formulation of Tesamorelin

Next week, the FDA will decide on Theratechnologies’ sBLA for its F8 formulation of tesamorelin, which it is proposing for the treatment of excess abdominal fat in adults living with HIV who have lipodystrophy. The regulator’s deadline is on January 22.

Tesamorelin is the only FDA-approved therapy in the U.S. to help cut abdominal fat in HIV-positive adults suffering from lipodystrophy. Currently, tesamorelin is approved in its F4 formulation, which is a single-vial formulation that is four times more concentrated than the original medicine, and is being sold under the brand name Egrifta SV.

The drug is a growth hormone-releasing factor analog that works by inducing the pituitary gland to secrete endogenous growth hormone, which in turn exerts its lipolytic effects to reduce abdominal fat.

The sBLA, which the company filed in September 2023, is backed by pharmacokinetic studies that have demonstrated the bioequivalence between the F8 formulation and the original F1 formulation of tesamorelin. By increasing the concentration, the F8 formulation allows for a smaller dose volume, delivered via a multiple-dose vial (MDV) that is reconstituted once per week.

If approved, the F8 formulation of tesamorelin will carry the brand name Egrifta MDV.

Heron Pushes for Expanded Use of Its Local Anesthetic

In December 2022, Heron Therapeutics filed a supplemental NDA (sNDA) for its local anesthetic Zynrelef (bupivacaine and meloxicam) extended-release solution, proposing its “greatly expanded” use in soft-tissue and orthopedic surgeries. The FDA’s verdict is due January 23.

Zynrelef is a dual-acting local anesthetic that uses a fixed dose of the anesthetic bupivacaine and a low dose of the non-steroidal anti-inflammatory drug meloxicam, which helps ease inflammation at the surgical site. According to the company’s website, this combination has been “clinically proven to better manage pain” versus the standard bupivacaine HCl solution.

Heron’s supplemental application is supported by safety and pharmacokinetic data from recently completed studies in patients undergoing C-section, abdominoplasty, spinal surgery and total shoulder arthroplasty. The totality of the data demonstrated comparable pain relief and safety to previous trials of Zynrelef, according to Heron’s news release of the sNDA’s submission.

Currently, Zynrelef is approved to induce postsurgical analgesia for up to 72 hours in adults who have undergone foot and ankle and small-to-medium open abdominal surgeries, as well as lower extremity total joint arthroplasty.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Back to news