The U.S. Food and Drug Administration has approved Inbrija (levodopa inhalation powder) for the treatment of Parkinsons off periods in patients on a carbidopa/levodopa regimen.
Acorda Therapeutics therapy is expected to be available by prescription in the first quarter of 2019. It will be distributed through a network of specialty pharmacies in the U.S.
Todays approval of INBRIJA marks a major milestone for both Acorda and the Parkinsons community, for whom we are gratified to have developed this much needed therapy, Ron Cohen, MD, Acordas president and CEO, said in a press release. Cohen noted the more than two decades of research and development needed for this approval, as well as the enormous perseverance and ingenuity by Acordas team.
Inbrija is a self-administered, orally inhaled levodopa treatment for off periods, which are characterized by the re-emergence of Parkinsons motor symptoms due to low levels of dopamine between doses of standard treatment. These off episodes are typically more common as the disease progresses.
The Michael J. Fox Foundation helped to fund the early development of Acordas medication, a decision based on the impact off periods have on patients lives, according to Todd Sherer, PhD, the foundations CEO.
We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control, he said.
Inbrija uses Acordas ARCUS technology, a system designed to deliver medication to the lungs through inhalation. ARCUS transforms molecules into a light, porous, dry powder, enabling the delivery of much higher doses of medication.
The FDAs decision was based on a clinical program that included approximately 900 Parkinsons patients. The pivotal Phase 3 SPAN-PD trial (NCT02240030) evaluated the efficacy and safety of 84 mg and 60 mg of Inbrija in 351 participants with mild to moderate Parkinsons who were experiencing off periods.
Results of the double-blind study showed a statistically significant improvement in motor function at the final 12-week visit, seen by a reduction in the Unified Parkinsons Disease Rating Scale Part III (UPDRS-III) score with Inbrijas higher dose, compared with placebo, at 30 minutes post-dose. Inbrijas effects were seen as early as 10 minutes after treatment.
The most common adverse reactions with Inbrija were cough, upper respiratory tract infection, nausea, and discolored sputum, which may indicate a bacterial infection.
Treatment with Inbrija was also analyzed in a one-year, randomized, open-label Phase 3 trial with 398 participants (NCT02352363). Results showed a similar average reduction in forced expiratory volume in one second a measure of pulmonary function in the Inbrija (84 mg) and observational groups.
Inbrija also eased Parkinsons symptoms at all time points, as measured with the UPDRS-III scale, enabled symptom control within 60 minutes of the dose and reduction of total daily off times, and led to improved Patient Global Impression of Change scores in 75% of patients, which reflects the patients assessment of treatment effectiveness.
In the clinical study program, Inbrija established its safety profile and demonstrated clinically meaningful improvements in motor function, said Robert A. Hauser, MD, a professor of neurology and director of the Parkinsons Disease and Movement Disorders Center at the University of South Florida. Inbrija helps address a significant unmet need for people with Parkinsons, and we look forward to adding this new treatment option to our armamentarium.
Inbrija is not to be used by patients currently on or treated with a nonselective monoamine oxidase inhibitor, such as the antidepressants and anxiolytics phenelzine or tranylcypromine, within the last two weeks.
The company is currently seeking EU approval for Inbrija.
Burkhard Blank, MD, Acordas chief medical officer, said he was delighted with Inbrijas approval and its upcoming availability for on-demand use, based on each patients needs.
We thank the FDA for a constructive dialogue throughout the development program and their partnership during the review cycle. We especially thank all those who volunteered for the Inbrija clinical trials, without whose commitment new medications could not be developed, he said.
He further noted the important role played by people living with Parkinsons, their care partners, researchers, clinicians and advocacy groups, to achieve FDA approval.