DCGI clears apomorphine for PD patients

February 6, 2019 0 By FM

The Drug Controller General of India, the country’s top drug regulator, has approved apomorphine hydrochloride infusion for Parkinson’s Disease patients. The drug approval, which was long awaited in India as there were only limited options of treatment available for the patients in the country, through the drug developed by UK-based Britannia Pharmaceuticals has been in the Western markets for long.

“So far the country had only two options of treatment for Parkinson’s disease — levodopa oral medication and Deep Brain Stimulation (DBS) surgery. Both these options have their limitations. For example, levodopa has its side effects when the diseases progress after the initial stage and DBS is expensive, and Indian patients are typically averse to surgery and chip implantation in the brain,” said Dr Anil Venkat, senior neurologist at Nanavati Hospital, Mumbai, which launched apomorphine treatment in association with Kings College in London in December.

Though levodopa is still the gold standard treatment to manage Parkinson’s disease, there are other issues associated with the oral medication for late-stage and elderly patients. This includes difficulty in swallowing and decreased movement of the stomach, called gastroparesis, Dr Venkat said in an interview with Future Medicine.

Though apomorphine treatment was approved in the West long ago, approval in India was pending for long. The drug, a dopamine receptor agonist and a highly selective dopamine receptor stimulator, is administered through an infusion pump with a subcutaneous needle as per the dosage requirement of the patient.

“Typically, a single injection of apomorphine lasts for 100 minutes, which is short acting. So, in the West, early stage patients are normally given an injection in the early morning when they wake up very rigid and stiff and they can’t take any oral medication. This shot will help them start the day and move on. But this is only in the initial stage, and they would require repeated injections as the disease progresses, and they start to freeze and not be able to move. Then, patients would require a continued release of the drug into the body using an infusion pump just like an insulin pump. That is the point of transition from injection to infusion,” says Dr Venkat.

“With apomorphine, we have the advantage of giving it with a pen as well as an infusion pump, with regulated release of doses as per the requirement of the patient. And the other most important advantage with apomorphine is that the result is pretty obvious as you will know if the patient is responding to the medication or not,” he said.

Parkinson’s disease is a progressive nervous system disorder that affects movement. Symptoms start gradually, sometimes starting with a barely noticeable tremor in just one hand. Tremors are common, but the disorder also commonly causes stiffness or slowing of movement. Although a complete cure is not possible as of now, the disease can be managed with medications with significant improvement in the symptoms.