In a first of sorts, drugmaker Rusan Pharma is unveiling apomorphine injections in the country, a product that helps tackle fluctuating motor functions in people with Parkinson’s disease.
Parkinson’s largely affects people over 60 years, though young people too have been reported to be suffering from the condition, Kunal Saxena, Rusan Pharma’s Managing Director told Business Line , adding the company’s indigenously developed injectible versions of the drug would be more affordable to local patients. Rusan has received the Drug Controller General of India’s approvals, he said. The product and support services are ready to be rolled out immediately.
Parkinson’s disease is progressive disease affecting nerve cells in the deep parts of the brain. The changing level of dopamine produced in the brain affects a patient’s motor functions, resulting in an “off state”; this leaves the person virtually incapacitated. The present standard of care is oral drugs or a brain surgery in severe cases, Saxena said.
Safety profile
The apomorphine injection comes between the two, Saxena said, as the disease progresses and oral drugs become less effective. It could also help those unable to undergo surgery, he added.
The injection is seen ending the “off state” within four to 10 minutes of administration. The alert and more coherent condition of patients is seen to last between 60 to 90 minutes, he said. To keep the alert state on for longer periods, there are delivery devices like a pump (to release the medicine into the body with greater regularity) and reusable pens. The product also tackles ‘non-motor’ symptoms associated with the illness such as depression and anxiety, he added.
The Aposan apomorphine injections are available in 2 ml and 5 ml ampoules (of 10 mg strength), priced at ₹315 and ₹700, respectively. With daily dosages ranging between 30 and 60 mg, he said, it would cost between ₹475 and ₹950, per day. Similar products in the UK cost about ₹2,250 to ₹4,500, he said. PP Ashok, Head of Neurology with Mumbai’s Hinduja Hospital said the product presented a “promising situation in a disease which leads us to a dead end after sometime, as there is no cure.” There has been no major discovery since L-Dopa, he said. Dispelling morphine linkages, Saxena said apomorphine is “non-narcotic, non-addictive and not a controlled substance,” and so can be sold as a regular prescription product by chemists.
The safety profile of the molecule is established, he said, as it has been in use the UK since 1994. In fact, the UK-based innovator of the product, Britannia Pharmaceuticals, is also reportedly seeking regulatory approvals to sell the product in India.
The product will be available in Mumbai, Delhi, Chennai and Bengaluru in January.