With manufacturing-related rejection, FDA turns its nose up at Satsuma's migraine nasal spray

Considering trial setbacks and cash concerns, Satsuma Pharmaceuticals faced an uphill climb to even file for approval of its migraine spray treatment at the FDA. Now, the agency has thrown another wrench in the company’s commercial hopes by issuing a manufacturing-related complete response letter.

In rejecting the application, the agency cited chemistry, manufacturing and controls concerns, Satsuma’s parent company, Shin Nippon Biomedical Laboratories, said in a press release. The agency did not flag issues with the clinical data package or request new trials.

“We remain committed to working expeditiously with the FDA to complete the review for STS101 as soon as possible,” Satsuma’s CEO Ryoichi Nagata, M.D., Ph.D., said in the release. The company will detail potential timing for a resubmission after consulting with the FDA.

The update is just the latest in a series of setbacks for Satsuma and its migraine asset, dubbed STS101. After coming up short two phase 3 studies, the company at one point gave up on attempting to commercialize the asset. That was until a later data analysis changed the company's mind.

In the hopes that STS101 could be an “attractive addition to the portfolio of an established pharmaceutical company,” Satsuma filed for approval in March. Then, it trimmed 36% of its workforce to save cash while seeking for a potential buyer.

Things were looking up when Shin Nippon, the Japanese nasal spray specialist that provided the delivery technology used in the migraine spray, swooped in to buy the drugmaker in April. The move was the “best strategic alternative” for Satsuma, former CEO John Kollins said in a statement at the time.

Despite the nasal spray missing its co-primary endpoints in late-stage studies, Satsuma has been hopeful that its secondary endpoints could support an approval. Those secondary endpoints were relief from pain and relief from a patient's most bothersome symptom two hours after dosing.

STS101 wouldn’t be the first nasal spray to enter the migraine market. Pfizer’s Zavzpret already staked that claim with its March approval in what the company hailed as a “significant breakthrough” for patients who prefer alternatives to oral meds. 

Satuma's hopeful is a nasal powder formulation of the long-approved migraine treatment dihydroergotamine.