- ScPharmaceuticals Inc (NASDAQ: SCPH) announced that after the Type A meeting with the FDA, the agency does not require any modifications to the device, nor it asked the company to conduct additional clinical studies to demonstrate the safety and efficacy of Furoscix.
- In December last year, the company received a Complete Response Letter due to the FDA's inability to conduct pre-approval inspections at two of scPharma's third-party manufacturing facilities due to travel restrictions.
- The letter also cited concerns regarding testing, labeling, and features of the combination product unrelated to the drug constituent, as well as deficiencies at the third-party facility where the company's off-the-shelf alcohol swabs are manufactured.
- The company still anticipates the need for inspections of the West Pharmaceutical Services facility in Scottsdale, Arizona, Sharp Packaging Services' facility in Allentown, Pennsylvania, and the third-party manufacturer of the off-the-shelf alcohol swabs.
- To address the FDA's outstanding questions, the company will conduct the modified bench testing, thus allowing it to refile the marketing application for Furoscix in Q3 of this year.
- Furoscix is a subcutaneous injection delivering furosemide as an outpatient alternative to treat worsening heart failure due to congestion.
- In parallel, the company is conducting a Phase 3 FREEDOM trial evaluating overall and heart failure-related costs for subjects treated with FUROSCIX for 30 days post-discharge from the emergency department compared to patients who remain in the hospital for less than or equal to 72 hours following hospitalization.
- Price Action: SCPH shares are down 1.3% at $6.83 on the last check Tuesday.
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