Sound Pharmaceuticals’ IND Involving Cochlear Implantation Allowed by the FDA
Sound Pharmaceuticals (SPI) is pleased to announce that it has received FDA notification that its Investigational New Drug Application (IND) may proceed involving SPI-1005 treatment and cochlear implantation (CI).
- Sound Pharmaceuticals (SPI) is pleased to announce that it has received FDA notification that its Investigational New Drug Application (IND) may proceed involving SPI-1005 treatment and cochlear implantation (CI).
- The Phase 2 trial will enroll 40 adults who are CI candidates and scheduled to receive a cochlear implant.
- This marks the 6th IND involving SPI-1005, which has been tested in 13 studies enrolling over 850 participants to date.
- SPI and MED-EL entered into an exclusive worldwide collaborative agreement involving the use of SPI-1005 with cochlear implants.