spine anatomy

Astellas Wins Expanded Label to Include Pediatric Use for Oral Solifenacin in the EU

Tokyo-based Astellas Pharma (TYO: 4503) has been awarded EU approval for its neurogenic detrusor overactivity (NDO) therapy solifenacin succinate in oral suspension form. The drug is indicated for children aged 2 to 18 years.  NDO is a bladder dysfunction in which increased storage pressure can put the upper urinary tract at risk of deterioration.  Commonly observed in patients with conditions such as multiple sclerosis and spinal cord injury, it causes urinary incontinence in approximately 50% of MS patients. Read more.

Source: The Pharma Letter, March 9, 2018

medical research

RDD Pharma Awarded CDMRP Grant for Clinical Drug for SCI Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application.  The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK.  “We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  “We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population.”  Read more.

Source: PRNewswire, September 14, 2017