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onabotulinum toxin A · 1 trial · 1 indication
Patient will record the pain intensity by means of a visual analogue scale (VAS, from 0-10 being 0 no pain and 10 the worst possible pain)
| Arm | Type | Description |
|---|---|---|
| BOTOX | EXPERIMENTAL | Onabotulinum toxin A is distributed in 50 unit (50U) vacuum-dried powder bottles by Allergan (BOTOX (R)) for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection prior to injection. 1 mL of diluent will be drawn up to obtain a resulting dose of 10 U per 0.2 mL and injected into the vial. The BOTOX(R) will then be gently mixed with the saline by rotating the vial. The date and time of reconstitution will be recorded on the package on the label. BOTOX should be administered within 24 hours after reconstitution and stored in a refrigerator (2-8 °C). Each patient will receive 50 U of onabotulinum toxin A. |
| Name | Type | Description |
|---|---|---|
| onabotulinum toxin A | DRUG | Each subject will receive 50 units (50 U) of BoNT-A constituted in 1 mL of saline solution injected intraorally to the painful area divided in at least 3 sites, 0.5 to 1.0 cm apart depending on the size of the painful area and following a checkerboard pattern. |
Inclusion Criteria: * History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out. * Intractable pain to conventional ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA |
| Dogwood Therapeutics Inc | DWTX | 1 | PHASE2 | Halneuron |
| Sangamo Therapeutics, Inc. | SGMO | 1 | PHASE1 | ST-503 |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | N/A | Undisclosed |
OnabotulinumtoxinA is used for forehead lines, neuropathic pain, osteoarthritis, overactive bladder, urinary incontinence, and forehead rhytides. It is being studied in clinical trials for these conditions, including lateral canthus rhytides (crow's feet lines) and urinary incontinence due to neurogenic detrusor overactivity in multiple sclerosis patients.
OnabotulinumtoxinA is a monoclonal antibody that targets the neuromuscular junction. It works by blocking the release of acetylcholine from nerve endings, which temporarily paralyzes muscles. This mechanism is used to treat conditions like forehead lines and overactive bladder by reducing muscle activity.
OnabotulinumtoxinA is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
OnabotulinumtoxinA is in Phase 3 clinical development for some indications, with Phase 2 trials also completed. It is an investigational drug and has not been approved by the FDA for the studied indications. The clinical program includes four completed trials with a total enrollment of 1,126 participants.
OnabotulinumtoxinA has completed four clinical trials, including NCT01189747 for crow's feet lines, NCT01600716 for urinary incontinence in multiple sclerosis, NCT02230956 for knee osteoarthritis, and NCT03320850 for overactive bladder. All trials were randomized, double-blind, and placebo-controlled.
OnabotulinumtoxinA is the same as BOTOX. Clinical trials reference BOTOX in their titles, such as NCT02230956 for knee osteoarthritis and NCT03320850 for overactive bladder. The drug is being studied under the brand name BOTOX by AbbVie.