FDA approves Botox to treat urinary incontinence
pharmafile | August 25, 2011 | News story | Sales and Marketing | Allergan, Botox, urinary incontinence
Botox has been approved in the US to treat urinary incontinence as manufacturer Allergan continues to expand the brand’s non-cosmetic uses.
The FDA approved Botox (onabotulinumtoxinA) to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis.
Scott Whitcup, Allergan’s executive VP of research, said: “Urinary incontinence due to detrusor overactivity in patients with a neurologic condition is a serious medical problem, and for people who do not respond to or cannot tolerate the side effects of an oral anticholinergic medication, Botox is a new long-lasting treatment option to reduce urinary incontinence episodes and address a particularly burdensome issue.”
The drug currently earns annual sales of around $1.3 billion, half of which comes from its well-known cosmetic licence to reduce wrinkles.
Analysts at Morgan Stanley estimate this latest approval will add just $59 million in annual revenues by 2015.
Current management of urinary incontinence for MS and spinal injury patients includes medications to relax the bladder and use of a catheter to regularly empty the bladder.
Botox contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum, and works by being injected directly into the bladder resulting in relaxation of the organ, an increase in its storage capacity and a decrease in urinary incontinence.
The effectiveness of the drug to was demonstrated in two clinical studies involving around 700 patients.
Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo for spinal cord injury or multiple sclerosis patients.
Earlier this month the Irish Medicines Board gave Botox a similar approval as its US counterpart, paving the way for its use as an incontinence drug in the EU.
Allergan is also looking to expand the drug into other therapeutic areas, and more recently Botox was approved in the US to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe under-arm sweating, abnormal twitch of the eyelid, and a condition in which the eyes are not properly aligned.
This week’s approval sees the seventh medical use for the drug in the country, but Allergan is hoping there will be more to come.
Morgan Stanley believes Botox could generate nearly $500 million more a year if, as they expect, the drug is approved to treat patients with overactive bladders for non-neurological reasons – a much larger market in the US.
Marketing breaches
The company has created an aggressive marketing machine to extol the virtues of its drug outside of cosmetics, an image it has found hard to shift.
But this aggressive stance has led to the US firm having to pay $600m to settle charges it illegally promoted and sold Botox for unapproved uses up until 2005, with the company later pleading guilty to a misdemeanour misbranding charge.
The company also felt the wrath of the UK Code of Practice regulator the PMCPA earlier this year for several breaches of the ABPI Code of Practice, which saw the firm ‘bring discredit upon and reduce confidence in the pharma industry’.
Ben Adams
Related Content
FDA rejects Allergan’s Abicipar pegol for neovascular age-related macular degeneration over benefit/risk concerns
The FDA has moved to reject Allergan’s vascular endothelial growth factor (VEGF) factor A inhibitor, …
$63bn Allergan/AbbVie merger review could be delayed by coronavirus
The $63 billion merger of major pharma players AbbVie and Allergan could be facing hurdles …
Allergan’s ubrogepant doses smash primary endpoints in acute treatment of migraine
New Phase 3 data has been released showing that both 50mg and 100mg doses of …
