Ongentys

Description

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Ongentys (opicapone) is a novel, long-acting alternative treatment for Parkinson’s disease (PD), approved by the US Food and Drugs Administration (FDA) in June 2020, and by the European Medicines Agency (EMA) in April 2016. Ongentys is indicated for adult patients with PD experiencing end-of-dose “wearing-off” motor fluctuations and optimised dopaminergic therapy  was developed and branded by Neurocrine Biosciences, in collaboration with Portuguese pharma company, BIAL.

PD is a chronic, progressive movement disorder, characterised by the degeneration of dopaminergic neurons in the substantia nigra, a region of the brain that influences motor control. This demise causes a deficiency of dopamine, a neurotransmitter involved in the regulation of movement, cognition, mood, and behaviour. As a result, PD patients often experience motor symptoms such as tremors, rigidity, bradykinesia (slowness of movement), and postural instability. Currently, there is no cure for PD, and treatments are aimed at mitigating the symptoms and improving the patient’s quality of life.

Ongentys is an inhibitor of catechol-O-methyltransferase (COMT), an enzyme which breaks down dopamine, levodopa, and other catecholamines in the brain and peripheral tissues. opicapone extends the half-life of levodopa, a precursor of dopamine, and reduces the fluctuations in plasma concentrations of levodopa and its metabolites. This creates more constant delivery of the drug to the brain, resulting in more stable control of PD symptoms.

opicapone is taken orally as a capsule, once daily, at bedtime, in combination with levodopa/carbidopa or levodopa/benserazide. The usual starting dose is 25 mg, which can be increased to 50-50 mg after one week of treatment based on individual response and tolerability. According to clinical trials, opicapone significantly increased “on” time without dyskinesia, reduced off time, and improved patients’ motor symptoms, compared to placebo. In a six-month phase III trial, opicapone was shown to increase “on” time without troublesome dyskinesia by 1.06 hours compared to placebo. This effect was sustained in a two-year extension study and was seen regardless of the patient’s age, sex, disease duration, or levodopa dose.

Moreover, opicapone also had a favourable impact on non-motor symptoms in PD, such as sleep quality, daytime sleepiness, and cognitive function. In a 14-week phase III trial, Ongentys significantly improved the Epworth Sleepiness Scale (ESS) score, indicating less excessive daytime sleepiness than placebo. Furthermore, opicapone improved the Scales for Outcomes in Parkinson’s disease – Cognitive function (SCOPA-COG) global score and the SCOPA-COG verbal fluency domain score, suggesting a cognitive-enhancing effect. These results are encouraging, given that cognitive impairment is a common and debilitating aspect of PD, affecting up to 25% of patients.

Unlike other COMT inhibitors, such as entacapone and tolcapone, Ongentys does not require dosing with every levodopa intake, due to its once-daily dosing regimen. Furthermore, opicapone has a low potential for hepatic toxicity, a common adverse effect of tolcapone, which led to its withdrawal or restriction in some countries. Although Ongentys might cause mild to moderate adverse effects, such as dyskinesia, hallucinations, constipation, or orthostatic hypotension, they were reported at similar rates as placebo. The most common side effect of Ongentys is an increase in the liver enzyme, alanine aminotransferase (ALT), which can be monitored through regular liver function tests.

With its improved efficacy and tolerability profile, Ongentys represents a valuable addition to the armamentarium of drugs for the management of PD. Ongentys can provide PD patients with a more flexible, convenient, and reliable treatment option, reducing the burden of their symptoms and improving their overall well-being. Furthermore, Ongentys’s potential to ameliorate cognitive function and sleep disturbances can enhance the patient’s quality of life further. Although Ongentys is not a cure for PD, its novel mechanism of action and advanced pharmacokinetic profile hold promise for the future development of therapies for PD and other neurological disorders.

In conclusion, Ongentys’s potential to improve sleep quality and cognitive performance, coupled with its safety profile, make it a welcome addition to the treatment options available for PD patients. With further studies, Ongentys’s benefits might extend to other patient populations with motor fluctuations, such as those with atypical parkinsonism or advanced PD. Ongentys is an exciting and transformative drug that represents not only hope but also a significant advance in the management of PD, bringing us one step closer to a cure.