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Saturday
Oral Inhalation of Apomorphine May Relieve "Off" Periods in PD
A new powdered formulation of apomorphine, administered by oral inhalation, may provide rapid, noninvasive relief from "off" periods for patients with Parkinson's disease, a phase 2 study suggests.
Donald Grosset, MD, a consultant neurologist at the Institute of Neurological Sciences, Southern General Hospital, in Glasgow, Scotland, was the principal investigator for this first clinical trial of the inhaled formulation, presented November 2 at the Movement Disorders Society's 10th International Congress on Parkinson's Disease and Movement Disorders.
"The clinical implications of the finding are that patients with more advanced Parkinson's disease could benefit from a noninvasive route of administration and a faster response when they enter an 'off' period," he told Medscape.
Further testing will be required for product license approval, Dr. Grosset added. Vectura Group PLC, the sponsor of this study, is continuing with the clinical trial development program for this application of inhaled apomorphine, he said.
New Administration Route
Apomorphine is a powerful dopamine agonist that is already used clinically as a subcutaneous injection, as intermittent injections to rescue from off periods, or as an infusion to stabilize treatment with constant-dose levels, Dr. Grosset pointed out. While both of these formulations are available in Europe, only the intermittent injections are available in North America and are used for the same indication as inhaled apomorphine.....
Patients successfully used the device, the authors point out, and reported it was easy to use.
Dr. Grosset and colleagues conclude that consecutive doses of this inhaled formulation are well tolerated. "VR040 has the potential as a noninvasive, rapidly acting, and user-friendly treatment for patients suffering motor complications associated with advanced PD," they write. "Further development of VR040, including higher dose strengths, will be pursued." MORE
A new powdered formulation of apomorphine, administered by oral inhalation, may provide rapid, noninvasive relief from "off" periods for patients with Parkinson's disease, a phase 2 study suggests.
Donald Grosset, MD, a consultant neurologist at the Institute of Neurological Sciences, Southern General Hospital, in Glasgow, Scotland, was the principal investigator for this first clinical trial of the inhaled formulation, presented November 2 at the Movement Disorders Society's 10th International Congress on Parkinson's Disease and Movement Disorders.
"The clinical implications of the finding are that patients with more advanced Parkinson's disease could benefit from a noninvasive route of administration and a faster response when they enter an 'off' period," he told Medscape.
Further testing will be required for product license approval, Dr. Grosset added. Vectura Group PLC, the sponsor of this study, is continuing with the clinical trial development program for this application of inhaled apomorphine, he said.
New Administration Route
Apomorphine is a powerful dopamine agonist that is already used clinically as a subcutaneous injection, as intermittent injections to rescue from off periods, or as an infusion to stabilize treatment with constant-dose levels, Dr. Grosset pointed out. While both of these formulations are available in Europe, only the intermittent injections are available in North America and are used for the same indication as inhaled apomorphine.....
Patients successfully used the device, the authors point out, and reported it was easy to use.
Dr. Grosset and colleagues conclude that consecutive doses of this inhaled formulation are well tolerated. "VR040 has the potential as a noninvasive, rapidly acting, and user-friendly treatment for patients suffering motor complications associated with advanced PD," they write. "Further development of VR040, including higher dose strengths, will be pursued." MORE