From the Executive Director
Dear HAPS Family and Friends,
This year marks the beginning of Houston Area Parkinson Society's 45th year of service to our local community. It all began in 1974 when a small group of families gathered together and established a Parkinson's Interest Group in the home of one of its members. The group was made up of only 18 individuals, their caregivers, and volunteers who wanted to focus on exercise, discussion, games and brown bag luncheons. In 1976, HAPS published its very first newsletter which went out to 288 households and in 1978, the organization received its very first grant in the amount of $7,500 from the George and Mary Josephine Hamman Foundation. This generous gift provided funds to operate four therapeutic exercise groups, one speech therapy group, and a lecture group. This would be a turning point that helped launch what became the cornerstone of HAPS programs leading to extensive growth bringing the total number of groups from 5 to more than 200.
It would be sixteen years before HAPS hired its first full-time Executive Director and another eight years before hiring a full-time social worker. It is amazing how much HAPS has changed over the years. HAPS now has six full-time employees, more than 20 independent contractors, a transportation program, respite care, emergency funds, and many educational programs to offer. However, despite 45 years of growth, the mission and the values of the organization have remained unchanged.
From it's inception, HAPS' main goal has been to meet the needs of those affected by Parkinson's disease by providing programs, services, and support so that no one has to face a Parkinson's diagnosis alone. HAPS has been able to accomplish this through the invaluable support of individual donors and Foundations, as well as the robust and energetic participation of those with PD and their family members. Just as HAPS began with people directly affected by the disease, our programs remain driven by need and feedback from those who can speak to the types of programs that will have the most impact in their lives.
We eagerly look forward to the year ahead and to continuing this long-standing tradition of meaningful service to the Parkinson's population. 2019 will bring with it exciting new changes. Look for additional staff and more programs throughout the year. There will be new avenues for sharing information and increased visibility and participation in local events. The new year will also bring a new look as the organization has been engaged in a thoughtful and important rebranding process which will influence how we tell our story and reinforce our dedication and reach into the community. We don't want to change what we do, but how we do it. This includes putting more programs and services back into our service area. HAPS knows that we are better when we work together and we enthusiastically welcome you to be a part of our journey this year!
Kathleen Crist, LMSW
FDA Approves New Parkinson's Medication
Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced December 21, 2018, that the U.S. Food and Drug Administration approved INBRIJA™ for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
“INBRIJA helps address a significant unmet need for people with Parkinson’s, and we look forward to adding this new treatment option to our armamentarium.”
“Today’s approval of INBRIJA marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much needed therapy,” said Ron Cohen, M.D., Acorda President and CEO. “This milestone resulted from over two decades of research and development, beginning in the laboratory of Dr. Robert Langer at Massachusetts Institute of Technology, through years of enormous perseverance and ingenuity by the entire Acorda team.”
“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” said Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation. “The Foundation provided funding for the early clinical development of INBRIJA because patients told us that OFF periods were one of their most serious issues. 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.”
“In the clinical study program, INBRIJA established its safety profile and demonstrated clinically meaningful improvements in motor function, as measured by the UPDRS Part III,” said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida. “INBRIJA helps address a significant unmet need for people with Parkinson’s, and we look forward to adding this new treatment option to our armamentarium.”
FDA approval of INBRIJA was based on a clinical program that included approximately 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing OFF periods. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks.
“I’m delighted that INBRIJA has been approved and may be added to patients’ existing Parkinson’s medications for on-demand use, based on individual patient need,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “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. And we are grateful for the people living with Parkinson’s, their care partners, researchers, clinicians and advocacy groups, who have all collaborated with us to help achieve this milestone.”
About the INBRIJA (levodopa inhalation powder) Clinical Development Program
The Phase 3 pivotal efficacy trial – SPANSM-PD – was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of INBRIJA in patients with mild to moderate Parkinson’s experiencing OFF periods.
The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the Week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for INBRIJA 84 mg (n=114) compared to placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points respectively; p=0.009). Onset of action was seen as early as 10 minutes.
The most common adverse reactions with INBRIJA (at least 5% and greater than placebo) in the pivotal trial were cough (15% vs. 2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and sputum discolored (5% vs. 0%).
INBRIJA was also studied in a Phase 3 long-term, active-controlled, randomized, open-label study (N=398) assessing safety and tolerability over one year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same (-0.1 L) for the INBRIJA and observational cohorts. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last five years were excluded from this study.
INBRIJA is expected to be commercially available by prescription in the U.S. in the first quarter of 2019 and will be distributed through a network of specialty pharmacies.