Onabotulinumtoxin A is under clinical development by AbbVie and currently in Phase II for Chronic Obstructive Pulmonary Disease (COPD). According to GlobalData, Phase II drugs for Chronic Obstructive Pulmonary Disease (COPD) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Onabotulinumtoxin A’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Onabotulinumtoxin A overview

Onabotulinumtoxin A (Botox / Vistabel) is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A. It is formulated as injectable powder solution for intramuscular, transdermal, subcutaneous and intradermal route of administration. Botox is indicated for cervical dystonia, chronic migraine, axillary hyperhidrosis, blepharospasm, strabismus, blepharospasm, muscle spasm, overactive bladder, and urinary incontinence. It is also indicated for focal spasticity, including the treatment of spasticity in ambulant paediatric cerebral palsy patients, wrist and hand disability due to upper limb spasticity and ankle disability due to lower limb spasticity associated with stroke, for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.

Botox is under development for the treatment of myofascial pain, chronic exertional compartment syndrome (CECS), episodic migraine prophylaxis, interstitial cystitis/bladder pain syndrome (IC/BPS), cold intolerance secondary to digital amputations and replantations, COPD, stress urinary incontinence (SUI), essential tremor, masseter muscle prominenceand dentoalveolar neuropathic pain.

It was also under development for the treatment of Incisional (Ventral) Hernia, non-relaxing puborectalis syndrome, benign prostatic hyperplasia, premature ejaculation, neuropathic pain, chronic prostatitis, chronic orchialgia, osteoarthritis pain, major depressive disorder, migraine, carpal tunnel syndrome, scleroderma-associated Raynaud's syndrome, trigeminal neuralgia, overactive bladder with urinary incontinence due to neurogenic detrusor overactivity and pruritus, spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy, pediatric lower limb spasticity, bilateral masseter muscle hypertrophy (MMH), complex regional pain syndrome, hypertrophic scarring, pediatric patients with neurogenic detrusor overactivity (overactive bladder), 

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic and rheumatological diseases, neurological disorders, skin diseases, rheumatoid arthritis, pain related to endometriosis, pediatric Crohn’s disease, cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of Crohn’s disease, Parkinson’s disease, neurological disorders, aesthetics, and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, healthcare facilities, government agencies, specialty pharmacies, and independent retailers. The company has operations in the Americas, Asia-Pacific, Europe, the Middle East and Africa. AbbVie is headquartered in North Chicago, Illinois, the US.

For a complete picture of Onabotulinumtoxin A’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 May 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.