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AUGUST 2018    A Monthly Review of Articles of Interest for the Clinical Community

..This Month's Clinical Focus:.NEUROLOGY / CNS..

 

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Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension now Available


Trial Shows Durable Improvements in nOH Symptom Severity Observed as Measured by OHSA Question #1

 

There are positive four-week results from a Phase 2 clinical trial of TD-9855, an investigational, once-daily norepinephrine and serotonin reuptake inhibitor (NSRI) in development for the treatment of patients with symptomatic neurogenic orthostatic hypotension (nOH). Top-line results from the study included durable improvements in patients' disease symptom severity after four weeks of treatment with TD-9855, as measured by Orthostatic Hypotension Symptom Assessment Question #1 (OHSA #1). OHSA #1 is a measure of dizziness, lightheadedness, or the sensation of being about to black out. Patients treated in the extension phase of the study showed a mean symptom improvement of 2.4 points at four weeks. Importantly, mean symptom improvement was greatest (3.8 points) in nOH patients who reported dizziness symptoms (OHSA #1 > 4) at baseline, a pre-defined regulatory and clinical threshold that will be used to enroll patients in Phase 3.

brain-3168269_1920 by VSRao PIXABAY Free Lic CC0 2

Additionally, TD-9855 consistently increased systolic blood pressure (SBP), including clinically meaningful increases in standing SBP at the three-minute assessment at all time points on all weekly clinic visits. There were no drug-related serious adverse events reported, and TD-9855 was generally well tolerated in the study. Theravance Biopharma has also concluded its discussions with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 registrational program and plans to initiate the program in late 2018 or early 2019.

About the Phase 2 Study in nOH
These top-line data were generated in a Phase 2 study of TD-9855 in neurogenic orthostatic hypotension (nOH) which consists of three parts. Part A is a single ascending dose (from 1 mg up to 20 mg based on patient response) designed to evaluate impact on blood pressure and standing time for TD-9855 as compared to placebo. Part B is a double-blind, single dose study designed to evaluate impact on blood pressure and standing time for TD-9855 as compared to placebo. Part B was discontinued when the trial was amended to include Part C, following the enrollment of ten patients in Part B (five on TD-9855; five on placebo). Part C is an open label extension to Part A designed to evaluate improvement in patients' symptoms and impact on blood pressure. Responders in Part A were eligible to enroll in Part C at up to their highest tolerated Part A dose, which included 5 mg, 10 mg and 20 mg. The primary endpoint of the study was measured after four weeks, although patients can continue to receive medication for up to five months.

About nOH

Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a sustained orthostatic fall in systolic blood pressure (SBP) of = 20 mm Hg or diastolic blood pressure (DBP) of = 10 mm Hg within three minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentration and head and neck pain. nOH is caused by autonomic nervous system (ANS) malfunction and is associated with several underlying medical conditions including multiple system atrophy (MSA), pure autonomic failure (PAF) and Parkinson's disease (PD).


SOURCE: Article usage courtesy of PRNewswire


FDA Accepts New Drug Application (NDA) to review Midazolam Nasal Spray, an investigational product for the acute treatment of seizure clusters

 

Midazolam Nasal Spray has been granted orphan drug designation by the US FDA for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, acute repetitive seizures)

 

  Midazolam Nasal Spray has also been granted Fast Track designation by the US FDA due to the high unmet need for patients and caregivers. The acceptance of this NDA could result in midazolam nasal spray being approved in the U.S. as an acute treatment for increased seizure activities in early 2019. If approved, midazolam nasal spray will be the first new medication approved to treat seizure clusters in more than 17 years.

brain-951845_1920 by Geralt PIXABAY Free Lic CC0

The application is supported by data from a Phase 3 clinical study (ARTEMIS 1 -Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), which evaluated the safety and efficacy of midazolam nasal spray in 292 patients.
 

"Managing seizure clusters remains a challenge for thousands of patients and caregivers, in the US and beyond, who live their lives each day with this debilitating condition," explained Jeff Wren, Head of Neurology and Executive Vice-President at UCB. "There is an unmet need for effective and convenient acute treatment of seizure clusters that can rapidly end ongoing seizures and potentially prevent or delay their reoccurrence."
 

Seizure Clusters are unpredictable, even when a patient is compliant with their current anti-epileptic drugs. When it comes to managing seizure clusters, it is important that patients have an acute care plan that includes access to a treatment they can take anytime or anywhere.
 

It is estimated that more than 150,000 people in the U.S. with refractory epilepsy also experience seizure clusters. These types of seizures pose multiple risks to patients, including repeated emergency room visits and related hospitalizations each year.
 

SOURCE: Article usage courtesy of PRNewswire


Image credits: Xray by VSRao & Brain/Puzzle by Geralt at PIXABAY Free Lic CC0

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