Botox was first approved as a treatment for strabismus and blepharospasm, rare eye conditions, in 1989. Now, it is approved for 11 different conditions including cervical dystonia, chronic migraines, overactive bladder, and more.
Now, a new application has been submitted to expand its indication for detrusor overactivity, which is associated with some types of neurologic condition like spinal cord injuries and spina bifida. This indication would be for patients 5 to 17 years old who are not having an adequate response to other therapies.
Botox is the only approved neurotoxin for adults who don’t respond well to anticholinergics. It works by temporarily reducing muscle contractions. Now, it could become an alternative option for pediatric patients with detrusor overactivity.
The research into this new pediatric indication is being completed by Allergan.
Detrusor is the bladder muscle. Overactivity of the detrusor is a result of a lack of communication between the bladder and the spinal cord. When this overactivity is not managed, surgery may be necessary to enlarge the bladder and prevent renal damage.
Detrusor overactivity can be caused by spina bifida, transverse myelitis, a spinal cord injury, and other neurologic conditions. For some of these conditions it is a very common side effect. For example, over 90% of all those diagnosed with spina bifida also have urinary symptoms.
So what are the current treatments for this condition? Anticholinergic therapies are the go-to treatment for this overactivity. However, if this new application is approved, Botox could become the first ever therapeutic option for those who don’t respond adequately to anticholinergics before surgery becomes a necessary last resort.
The study which has provided hope to researchers about Botox as a therapeutic option for detrusor overactivity and encouraged them to submit the application, was a Phase 3 clinical trial. This trial was double-blind and randomized. It aimed to evaluate both the safety and the efficacy of this therapy in over 100 patients.
All of the participants in the trial experienced detrusor overactivity due to a neurological condition.
The researchers also completed a long-term extension study.
The positive results from these investigations have led to the submission of an application to the FDA. By the first quarter of 2021, more information should be released.
You can read more about this potential new therapy here.