19 December 2022 | Monday | News
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Ongentys (opicapone) is BIAL’s proprietary third-generation peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.
Australia’s Therapeutic Goods Administration (TGA) has authorized Ongentys (opicapone) 50mg capsules as a once-daily adjunctive therapy to preparation of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. The recommended 50mg daily dose of opicapone should be taken once per day at bedtime, preferably without food, at least one hour before or after levodopa combinations.
STADA anticipates launching the brand with reimbursement through Australia’s Pharmaceutical Benefits Schedule (PBS) system within the next few months. According to a TGA’s Australian Public Assessment Report (AusPAR) for opicapone, Parkinson’s disease currently affects around 40,000 Australians. Approximately one to two people per 1,000 are estimated to have the disease, with the incidence increasing to one in 100 of people over the age of 60. The disease is slightly more common in men than in women.
"Ongentys represents an ideal addition to STADA’s offering for Australian Parkinson’s disease patients and their caregivers, complementing our existing apomorphine-based Movapo therapies as well as our TRIDOPA," commented STADA’s Head of Specialty Care, EVP, Bryan Kim. “We look forward to making this once-daily oral treatment option available through the PBS in the coming months.”
BIAL’s Strategy & Business Development Director, Mark Duffy remarked: “We are pleased to work with STADA, which has a proven expertise in the treatment of Parkinson’s disease, and to bring this important treatment option to Australian Parkinson’s patients. This agreement represents another relevant step towards the extensive commercialization of BIAL’s innovative medicines, addressing the needs of patients and healthcare professionals worldwide.”
STADA has considerable heritage and experience in offering Australian patients and healthcare professionals Movapo (apomorphine) autoinjector pens, pre-filled syringes and ampoules. It is now adding a new oral therapeutic option, Ongentys (opicapone), to its Parkinson’s disease armamentarium.