FDA Approved Drug Shows Promising Outcomes in Treating Parkinson’s Disease

There’s currently no standard treatment available that can combat Parkinson’s disease (PD) but there are some relaxants such as levodopa/carbidopa that can be used to ease the pain and give relief to the symptoms.

However, Sunovion Pharmaceuticals Incorporation (SPI) has announced that the Food and Drug Administration (FDA) has approved a drug known as ‘Kynmobi’ (apomorphine hydrochloride)  also known as APL-130277 to treat the OFF episodes of PD in which APOKYN (apomorphine hydrochloride injection) is injected in the body of advanced PD patients to control the symptoms such as muscle stiffness, slow movements, and difficulty starting movements.

In recent years researcher’s primary focus has shifted towards the source, management, treatment, and slowing down the progression of PD which is a slow but chronic progressive neurodegenerative disorder of old age (≤60) in which degeneration of dopamine-producing neurons occur which takes years to progress and manifest its symptoms.

Dopaminergic neurons are responsible to control and coordinate body movements and once this depletion reaches severe levels, Parkinson’s disease diagnosis becomes inevitable. The disorder is characterized by shaking limbs, stiffness of muscles, and slowness of movement (bradykinesia).

Source: Froedtert- Medical College of Wisconsin

Above 1 million Americans are living with PD and almost 15% of the people inherit the disease resulting from genetic variations in different genes, according to an estimation by the Johns Hopkins Medicine Organization (JHMO). Studies show that when 80% of the dopamine-producing cells die, the disease begins to exhibit its debilitating effects on the health.

Source: Parkinson’s Foundation

Overview of Kynmobi And How it Works For PD Patients

Keymobi is a Sublingual Film formulated by apomorphine which is a dopamine agonist, mimicking the effects of dopamine in the brain.

Previously, levodopa was considered to be the most prescribed medication for the patients of PD that control the abnormal body movements and works as a relaxing agent for the rigidity in muscles. But from recent years, most of the patients experienced abnormal motor movements. It is now considered that the effectiveness of levodopa is fading away.

So, Kynmobi is taking its place which is now at 2nd trial phase-in is the only fastest way to reverse the symptoms from OFF episode of PD that can be used up to five times a day. It was previously available in the form of Apokyn, an injectable medication.

OFF Episode of PD: It refers to the worsening of the symptoms of a PD patient in the morning time when medicine does not work well.

ON Episode of PD: It refers to a sudden and unexpected loss of muscle control in people with advanced PD.

The investigators collected a randomized sample that was comprised of 109 patients diagnosed with OFF episode of PD. they divided the data into two groups including the Kynmobi group and the placebo group.

Initially, to assess the drug’s safety, effectiveness, and tolerability. Both of the groups were given the dose of 10 mg- 35 mg of Kynmobi whereas, a normal dose is 10 mg to 30 mg. The patients received the treatment for five times a day for consecutive 12 weeks with a combination of their anti-parkinsonian medications.

Later, the team used The Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) to observe whether there is any reduction in the severity level of the symptoms of PD. MDS-UPDRS comprised of 50 assessment question that helps in identifying the motor and non-motor symptoms that linked with PD.

After analyzing the outcomes, the team determined that the findings of the MDS-UPDRS showed that the Kynmobi group had 11.1 point reduction and the placebo group showed 3.5 points reduction in symptoms.

The investigators also found out that in just 15 minutes after receiving medication the patients began to show changes in the body and the positive outcome persisted up to 90 minutes. In just 30 minutes, Kynmobi was also proven to be effective in achieving full control over muscle movement in 31% and 14% of the patients from the Kynmobi group and placebo group, respectively.

The patients experienced some common side effects including nausea, sleepiness, and dizziness in response to the medication. One death due to cardiac failure has been reported in this trial as the person had some cardiac risk already.

CEO of The Michael J. Fox Foundation for Parkinson’s Research (MJFFPR), Todd Sherer, Ph.D. said: “We know from our research and discussions with the Parkinson’s community that OFF episodes can significantly disrupt a patient’s daily life. The Foundation supported early clinical development of sublingual apomorphine, and this approval brings an important new treatment option for people with PD [Parkinson’s disease] who experience OFF [periods].”

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