product approval introduction

Ipsen Receives Positive Opinion In Europe for Dysport® In the Management of Urinary Incontinence In Adults With Neurogenic Detrusor Overactivity Due to Multiple Sclerosis or Spinal Cord Injury

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Dysport® (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are regularly performing clean intermittent catheterization (CIC).  This positive opinion for Dysport® now permits individual European country Health Authorities to grant national approvals, according to their country regulations.  In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union. Read more.

Source: Globe Newswire, June 9, 2022

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Topical Gel Gets Fast-Tracked for Fecal Incontinence in Spinal Cord Injury Patients

The Food and Drug Administration (FDA) has granted Fast Track designation to RDD-0315, a novel topical gel for the treatment of fecal incontinence in spinal cord injury patients.  RDD-0315 contains the alpha-agonist oxymetazoline in a topical gel formulation; it works by contracting the internal anal sphincter muscle. In a randomized, controlled crossover study involving 19 patients with spinal cord injury, the investigational gel was found to be beneficial, due to the local effect of oxymetazoline; a statistically significant reduction in the number of fecal incontinence episodes was observed 8 hours and 12 hours post-administration. Read more.

Source: MPR, February 15, 2019

Magnetic Stimulation Restores Bladder Control in Paralyzed Men

Patients with spinal cord injuries report that in addition to paralysis the lack of bladder control is one of the most troubling issues. At University of California Los Angeles, researchers have shown that they were able to restore significant bladder control to five men that suffered through spinal cord injuries years prior to treatment. The researchers used transcutaneous magnetic spinal cord stimulation as their technique, delivering pulses of focused magnetic fields to the site of the injuries. Similar technology was just cleared in the United States to treat obsessive compulsive disorder. Read more.

Source: Medgadget, August 22, 2018