Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

R-baclofen hydrochloride*

CAS No.

63701-55-3

Innovator/marketer

N/A

Polymorphic form

Crystalline HCl form

Therapeutic Area

Musculo-skeletal system

Status

Pipeline

EU DMF readiness

Q4 2018

US DMF readiness

Q4 2018

rug description:

Baclofen is a muscle relaxer and an antispastic agent.
Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from disorders such as multiple sclerosis and other spinal lesions, including tumours of the spinal cord, motor neurone disease, syringomyelia, transverse myelitis and traumatic partial section of the spinal cord. Baclofen is indicated for adults and children in the relief of spasticity of voluntary muscle arising from conditions such as cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis.

Mechanism of action:

Arbaclofen acts as selective GABAB receptors agonist. GABA (gamma-aminobutyric acid) is the major inhibitory neurotransmitter in the brain. Its production, release, re-uptake and metabolism occur in the nervous system.

* product not covered by a compound patent in the territory of Poland

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

OK