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h-Patch Device for Slow Apomorphine Infusion May Ease Off Periods in Advanced Parkinson’s, Valeritas Says

apomorphine treatment

Under-the-skin infusions of low-dose apomorphine using a wearable device called h-Patch may help in avoiding off periods and improving motor function in Parkinson’s patients, Valeritas, the technology’s developer, reports.

A preclinical study found that apomorphine delivered using h-Patch could be detected in the blood within two hours, with a gradual decline upon completing the 24-hour subcutaneous infusion. Valeritas is planning to present these results at an upcoming medical conference.

Apomorphine is a derivative of morphine with effects similar to dopamine, the neurotransmitter released by specialized neurons that are progressively lost in Parkinson patients. In patients with advanced disease, apomorphine is the only approved option for the acute treatment of off episodes, or periods when the medication wears off and before a new dose can be taken. Off periods are characterized by the resurgence of motor and non-motor symptoms.

It is available in the U.S. as an under-the-skin injection (Apokyn, by US WorldMeds), but has been associated with pain and injection-site reactions.

In prior clinical trials, single-dose, subcutaneous infusions of apomorphine have shown efficacy in suppressing off periods, reducing dyskinesia — involuntary, jerky movements — and improving motor scores of Parkinson’s patients. They also enabled significantly lesser use of levodopa, which has been associated with reduced effectiveness and with impulsive and compulsive behaviors when used for a number of years.

Infusion pumps in current use can be bulky, “requiring delivery of relatively large volumes of therapeutics [to] remain a barrier” to both patients and caregivers, Valeritas states a press release.

“This study highlights a new subcutaneous delivery of an old drug (apomorphine) which is commonly used in Parkinson’s,” said Santosh Kesari, chair and professor of Translational Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute and Pacific Neuroscience Institute, both in California.

The h-Patch approach, Kesari added, “may offer a more consistent dose throughout the day” relative to oral dosing of apomorphine, and help improve functionality and quality of life. “Drug delivery for CNS disorders is still a significant barrier for optimizing new and old drugs,” he said.

Valeritas’ V-Go Wearable Insulin Delivery device for people with type 2 diabetes, which also uses the h-Patch technology, is marketed in the U.S. with the approval of the U.S. Food and Drug Administration.

“Valeritas continues to demonstrate the versatility of, and opportunities for its h-Patch technology beyond insulin delivery,” said John Timberlake, the company’s president and CEO.

“The h-Patch is a demonstrated patient-friendly, cost-effective, and powerful delivery method for a variety of therapeutics which we believe is ideal for subcutaneous delivery of apomorphine,” he added.

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EVER Pharma Expands European Market for D-mine Pump for Delivering Parkinson’s Therapies

Sensile Medical micro pump

D-mine Pump, a portable micro-infusion pump designed to continuously deliver therapies under the skin (subcutaneously) to patients with Parkinson’s disease, has received the European CE approval and now will be marketed in several European countries.

CE means “European Conformity,” a certification mark that indicates conformity with European health, safety, and environmental protection standards.

The D-mine pump, according to a press release from its developer EVER Pharma, is safe and easy to handle, which is especially important given Parkinson’s patients increased difficulty in coordinating movement. The pump is compact, has minimal buttons, a simple screen interface and multiple languages.

A full day’s treatment can be set up just once a day. Moreover, the pump has automatic filling, and does not require complicated flow rate calculations. This prevents patients from having to adhere to strict timetables in their daily life.

Continuous administration of therapies may be required for patients who need multiple and frequent injections, or for those patients whose disease is not sufficiently controlled by intermittent injections. Furthermore, continuous infusion of a medicine is fast and efficient, and provides consistent control.

“CE approval of the D-mine Pump and the launch, is an important milestone for our product portfolio in Parkinson´s disease. EVER Pharma is now able to deliver an enhanced and comprehensive package of care with its Parkinson´s disease medication Apomorphine and its own Medical Devices”, said Dominic Benning, head of dopaminergic therapy at EVER Pharma.

“With the development of the EVER Pharma D-mine Pump for Parkinson’s therapy, we have realized a very ambitious project with challenging requirements. This considerable investment in this product is a clear statement of the spirit of EVER Pharma to put focus on patients’ needs and support with customized solutions. EVER Pharma delivers a complete package with its Parkinson’s disease portfolio, from medication to means of administration with innovative Medical Devices,” added Georges Kahwati,  manager of EVER Pharma.

D-mine pump is part of EVER Pharma’s therapy package for Parkinson’s disease, which also includes D-mine Pen and Dacepton (apomorphine hydrochloride), EVER Pharma’s injectable therapy for motor fluctuations, or “off episodes”, in Parkinson’s patients.

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