Advancements In Osmotica Pharmaceutical’s CNS Pipeline For Spasticity In MS Patients And LID In Parkinson’s Patients

MARIETTA, Ga.--(BUSINESS WIRE)--Osmotica Pharmaceutical Corp. provided an update today of its late stage CNS portfolio.

“Osmolex™ ER is a once a day treatment for a highly unmet medical need for Parkinson’s disease patients with Dyskinesia; we look forward to seeing this innovative formulation become available to our patients”

Over the last two decades Osmotica has developed the Osmodex™ technology and is one of the industry’s leaders in osmotic drug delivery technology. With its global footprint, Osmotica and its partners have a portfolio of marketed products which utilizes the Osmodex™ delivery platform including multiple ANDA and NDA products approved in the US. Osmotica has a robust patent portfolio around the osmotic delivery platform, with over 100 patents issued worldwide.

In early 2015, Osmotica successfully completed Phase III trials for Ontinua^TM ER (arbaclofen) extended-release tablets for the treatment of spasticity in patients with multiple sclerosis (MS) which leverages the Osmodex™ drug delivery platform. Multiple Sclerosis is the most common inflammatory disorder of the central nervous system. More than 2.5 million patients suffer from multiple sclerosis worldwide with 400,000 in the US. Of the 2.5 million patients, over 50% will suffer from spasticity.

“Spasticity is common in patients with multiple sclerosis and Ontinua ^TM ER given twice a day was shown to be an effective treatment based on the Modified Ashworth Scale and the Clinical Global Impression of Change as co-primary endpoints in the clinical study,” said Daniel Kantor, MD, FAAN, President of Kantor Neurology, Immediate Past President Florida Society of Neurology and a member of the Osmotica’s Scientific Advisory Board.

Osmolex™ ER (amantadine) extended release tablets is the second late stage NDA asset in Osmotica's CNS portfolio and is being studied for the treatment of levodopa-induced dyskinesia (LID). LID is a movement disorder associated with the treatment of Parkinson's disease. Parkinson’s disease is a degenerative disorder of the central nervous system mainly effecting motor skills. More than 4 million patients worldwide suffer from PD with over 700,000 in the US. Of all the patients treated for Parkinson’s disease 70% are on Levodopa therapy and more than 30% will develop symptoms of LID. Currently no drug is approved in the United States indicated for the treatment of LID.

The active drug in Osmolex™ ER has been formulated to provide a once daily administration in the morning. Two different dosage strengths of extended release amantadine were selected for phase III studies based upon promising results from a Phase II clinical study in 79 Parkinson’s disease patients with dyskinesia. Osmolex™ ER also employ’s Osmotica’s proprietary drug delivery technology, Osmodex™.

The following two Phase III clinical studies were commenced in early 2014 for Osmolex™ ER in the United States, Canada, France, Germany and Spain.

• ALLAY-LID I: a 16 week study with 162 patients; and
• ALLAY-LID II: a 26 week study with 162 patients.

“Osmolex™ ER is a once a day treatment for a highly unmet medical need for Parkinson’s disease patients with Dyskinesia; we look forward to seeing this innovative formulation become available to our patients”, said Mark Stacy, MD, Professor of Neurology, Vice Dean for Clinical Research, Department of Neurology, Duke University School of Medicine and Chair of the Osmotica’s Scientific Advisory Board.

Osmotica Pharmaceutical anticipates that it will file a new drug application via a 505(b) (2) submission for Osmolex™ ER in 2016. Additional information on the ALLAY-LID I and ALLAY-LID II studies can be found on www.clinicaltrials.gov.

In addition to these late stage NDA programs, Osmotica’s pipeline contains multiple CNS projects in early stage development. Osmotica Pharmaceutical and its related companies form an international group of companies with principal operations located in the United States, Argentina and Hungary.

For more information on the Company, please visit Osmotica’s website at www.osmotica.com. This press release is directed to residents of the United States.