ScPharmaceuticals has outlined plans to submit its heart failure candidate Furoscix for FDA approval for a third time later this year. The company expects to be ready to refile once it has completed work including modified bench tests on aged commercial units of its on-body drug delivery system.
Furoscix is designed to give patients with worsening heart failure and reduced responsiveness to oral diuretics a way to self-administer furosemide. The product administers the generic diuretic through a wearable, preprogrammed on-body drug delivery system. ScPharmaceuticals sources the delivery technology from West Pharmaceutical Services.
Having seen the FDA reject a filing for approval of Furoscix late last year, scPharmaceuticals has now received the minutes of its meeting with the agency to determine the next steps for the candidate.
Based on the FDA feedback, scPharmaceuticals expects to refile for approval without running further clinical efficacy, pharmacokinetic or safety studies. Equally, the FDA has not requested modifications to the drug delivery device.
The FDA does want to see more data on the device, though. ScPharmaceuticals plans to satisfy the request by running additional modified bench tests on aged commercial units of the on-body infuser provided by West. Preapproval inspections of facilities run by West, Sharp Packaging Services and a third-party manufacturer of off-the-shelf alcohol swabs are another prerequisite to approval.
Analysts at Jefferies said they “continue to see Furoscix as an eminently approvable product.” If, as scPharmaceuticals expects, the re-submission happens in the third quarter, Furoscix could be on the market next year. The Jefferies analysts calculate scPharmaceuticals has enough cash to launch the product and make it into 2023.
The planned re-submission is the latest event in a multiyear regulatory saga. ScPharmaceuticals first filed for FDA approval of Furoscix in late 2017, only for the agency to hit it with a complete response letter the following year. The letter cited the need for more human factors studies, modifications to the device and potentially a clinical validation study.
It took scPharmaceuticals about two years to gather the evidence needed to refile for approval. The FDA accepted the application for review in July 2020 and committed to making a decision on it by the end of the year. In December, the FDA hit scPharmaceuticals with a second complete response letter.