January 21, 2026 -- Rosemont Pharmaceuticals Announces License Agreement with Fidelity Biopharma to Market ONTRALFY™ (tizanidine oral solution) for Treatment of Spasticity in Adults.
Product will be available nationwide in February
Rosemont Pharmaceuticals has announced a license agreement with Fidelity BioPharma Company to market ONTRALFY™ (tizanidine oral solution 2 mg/5 mL) in the United States. Product will be available nationwide in February.
ONTRALFY is the first FDA approved oral solution of tizanidine, a central alpha-2-adrenergic agonist indicated for the treatment of spasticity in adults.1
ONTRALFY presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons. It is typically prescribed when spasticity interferes with daily life.
About 12 million patients suffer from spasticity worldwide.2 In patients whose spasticity is related to neurological conditions, such as stroke, spinal cord injury, multiple sclerosis, and Parkinson’s disease, among others, the prevalence of swallowing difficulties is increased.3,4,5 As an oral solution, ONTRALFY provides an effective and precise dosing option for these patients.
“The licensing of ONTRALFY allows Rosemont Pharmaceuticals to continue our mission of providing alternative dosage form medicines in a variety of therapeutic areas,” said John Denman, Vice President US Business Unit at Rosemont Pharmaceuticals. “ONTRALFY delivers an effective treatment option for muscle spasticity, now in a form that makes it accessible to patients who might not have been able to take it as a tablet or capsule.”
Rosemont Pharmaceuticals is a global pharmaceutical company specialized in the development and commercialization of alternative dosage forms. Rosemont was founded more than 50 years ago and sells over 130 liquid products in more than 27 markets.
Fidelity BioPharma is a pharmaceutical company focusing on and committed to bringing the innovated finished dosage formulation, medical device and medically functional nutraceuticals, with the highest level of quality, to global consumers. Fidelity aspires to contribute to the healthcare industry through the right partnerships and the right products.
References
1. Prescribing Information PI-TIZ-01-001. Rosemont Pharmaceuticals, LLC; 2025.
2.https://www.researchandmarkets.com/reports/6102503/spasticity-epidemiology-forecast
3.https://www.mdsabstracts.org/abstract/prevalence-of-oropharyngeal-dysphagia-in-hereditary-spastic-paraplegias/
4.https://www.numberanalytics.com/blog/dysphagia-prevalence-comprehensive-review
5.https://www.aapmr.org/docs/default-source/default-document-library/aapmr-spasticity-summit-background-paper_final_branded.pdf?sfvrsn=3ce7317c_0
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