Astellas Receives FDA Approval for VESIcare (Solifenacin Succinate) Oral Suspension – First Treatment for Neurogenic Detrusor Overactivity in Children Aged 2 Years and Older

May 27, 2020 /BioValleyBIOON/ -- U.S. Food and Drug Administration (FDA) Recently approved Astellas’ drug VESIcare (solifenacin succinate) oral suspension (LS), an oral liquid formulation for children aged ≥2 years, to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction associated with neurological injury.

VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder (OAB) in adults aged ≥18 years.

Christine P. Nguyen, Acting Director of the Division of Urology and Obstetrics & Gynecology within the Office of Rare Diseases, Pediatrics, and Urogenital Medicine at the FDA’s Center for Drug Evaluation and Research, stated: “This isFDAThe first approved treatment regimen for NDO patients as young as 2 years of age. Furthermore, prior to today’s approval, the current standard of care for many of these patients required up to three daily doses, whereas this new therapeutic agent requires only once-daily administration.”

Neurogenic Detrusor Overactivity (NDO) is bladder dysfunction caused by neurological diseases or injuries. NDO may be associated with congenital disorders (typically present from birth or before birth).Geneticsneurogenic diseases), such as spina bifida (myelomeningocele) or other conditions, such as spinal cord injury. In NDO, the detrusor muscle exhibits overactivity, whereas it normally relaxes to store urine. Detrusor overactivity leads to paroxysmal contractions of the bladder muscle, thereby increasing intravesical pressure and reducing bladder capacity. If NDO is left untreated, elevated intravesical pressure poses a risk of upper urinary tract damage, including potential permanent renal impairment. Furthermore, involuntary detrusor contractions can result in accidental and frequent urinary leakage, with symptoms including urgency, frequency (urination more often than normal), and urinary incontinence (loss of bladder control).

VESIcare LS Efficacy in the Treatment of NDO in 2 StudiesClinical TrialThese findings were confirmed in clinical trials. A total of 95 pediatric patients aged 2 to 17 years with neurogenic detrusor overactivity (NDO) were enrolled in these studies, which evaluated the maximum cystometric capacity (as the primary efficacy endpoint) after 24 weeks of treatment. In the first study, 17 patients aged 2 to less than 5 years demonstrated a mean increase of 39 mL in bladder capacity compared to baseline. In the second study, 49 patients aged 5 to 17 years showed a mean increase of 57 mL in bladder capacity compared to baseline. Reductions in spontaneous detrusor contractions, intravesical pressure, and episodes of urinary incontinence were also observed in both studies.

Clinical TrialsAmong the most common side effects of VESIcare LS are constipation, dry mouth, and urinary tract infections. Solifenacin succinate (the active ingredient in VESIcare LS) has been reported to cause drowsiness. Elderly patients capable of driving or operating heavy machinery should not engage in these activities until they understand how VESIcare LS affects them. In patients taking strong CYP3A4 inhibitors, healthcare providers are advised not to exceed the recommended starting dose of VESIcare LS. Serious allergic reactions, such as angioedema (subcutaneous swelling) and anaphylaxis, which may be life-threatening, have been reported in patients treated with solifenacin succinate. If a patient experiences swelling of the tongue or throat or difficulty breathing, immediate medical attention should be sought.(Bio Valley Bioon.com)

Original Source:FDA approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age