Rusan Pharma launch APOSAN for the treatment of Parkinson disease

Rusan Pharma announced the launch of APOSAN-Apomorphine Hydrochloride (HCl), being the only company in India to receive an approval from the DCGI. It is India’s first product to be indigenously developed and manufactured by Rusan. APOSAN is used for the treatment of motor fluctuations ("ON-OFF") in patients with Parkinson’s disease (PD) which are not sufficiently controlled by oral anti-Parkinson’s medication currently available in India. APOSAN will be available in the form of injections, pen and continuous infusion pumps.

Rusan is a fully integrated global pharma player which is one of the few manufacturers globally of the active pharmaceutical ingredient (API) – Apomorphine Hydrochloride and has now launched the finished formulation approved by the Indian DCGI, thus ensuring continuous supplies for the Indian PD patients. Rusan has been exporting it’s API to the global market where the finished formulation has been available for than a decade.

PD is a long-term degenerative disorder of the Central Nervous System (CNS) that mainly affects the motor system. PD is also one of the most common neurodegenerative diseases affecting the aging population and is associated with increased morbidity and mortality. It eventually causes severe disability due to the increasing severity of treatment-resistant motor problems and non-motor symptoms. Despite it’s name, Apomorphine as a molecule is structurally not similar to morphine and is hence not a controlled or addictive medicine.

The economic burden related to PD in India will continue to escalate. As per global, regional and national burden of PD, in 2016, the deaths due to PD in India were 17,539; prevalence is 5,75,946 and over 3 lakh people with Disability Adjusted Life Years (DALY’s).

Currently, in India only oral treatments such as levodopa and carbidopa combinations are used. In the PD patients, the gastrointestinal system is compromised, resulting in side effects such as absorption issues, constipation and dysphagia (swallowing difficulties). As a result, the optimisation of oral treatment in moderate to advanced PD patients is a challenge that may lead to sub-optimal response, delayed time to "ON" or dosage failure. To overcome these challenges, injectable form of Apomorphine has been the need of the hour.

Apomorphine has a reliable, rapid onset of action (4-10 minutes) and the duration of action is upto 60 to 90 minutes. Apomorphine is the most efficacious drug for not just managing the motor fluctuations (OFFàON) but also non-motor symptoms of Parkinson’s disease such as sleep problems, depression, anxiety, pain and urinary dysfunction. Studies show that 68 per cent of the patients report reduction in hallucinations. 58 per cent of the patients reported a reduction of ‘OFF’ time (both duration and severity of dyskinesia). 85 per cent reported improvement in night time sleep problems from insomnia, and hypersomnia to rapid eye movement (REM).

Commenting on the launch, Dr Kunal Saxena, MD, Rusan Pharma said, "Rusan, has always put forward indigenously developed high technology advanced delivery products in the Indian market. Being a Make in India product, we want to ensure the treatment is affordable and accessible to all PD patients. Since, PD (Parkinson disease) is a chronic disease, we aim to bring the per day cost to patients down to an affordable price. With APOSAN, the cost of the product for a daily dose (between 30 – 60 mg), in India will range between ₹ 475 to ₹ 950 per day as compared to Apomorphine Pens in the UK ranging between ₹ 2,250 to ₹ 4,500 per day. To make the therapy even more affordable and ensuring ease of use, we will be launching the APOSAN pens and APOSAN continuous infusion pumps which will be provided free of cost to the patients with Rusan’s APOSAN therapy. APOSAN will be available pan India by January 2019. With the APOSAN therapy, Rusan will also be launching the APOSAN Hope Programme which will comprise of Hope Nurses who will offer support free of cost to doctors, nurses, patients and their caregivers on the safe and effective use of APOSAN range of products.

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.