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The expectations and goals for treating epilepsy have recently been reset to a higher bar due to a number of new drug treatments entering the market, as well as UCB’s filing for brivaracetam in January of this year. However, high unmet need remains for refractory seizure conditions, including one of the most challenging, status epilepticus (SE). Status epilepticus is a condition of prolonged seizures that can be life-threatening. It occurs most commonly in the first year of life and in epilepsy patients who are over 60 years (1).

 

 

Citeline’s attention was recently captured by the fast-tracked SE treatment, SAGE-547, a GABA pathway modulator by Sage Therapeutics as a potential new therapy for multiple forms of epilepsy. The GABA pathway is currently an important target in epilepsy drug development, as illustrated by Citeline’s Trialtrove data (Figure 1), showing that 62% of pipeline drugs with a defined target are focused on this mechanism.

 

 

Figure 1. GABA Modulators Dominate the Industry-sponsored Epilepsy Trial Landscape.

 

 Epilepsy-blog-chart-1

 

Source: Trialtrove® , May 2015

Our sister service, Pharmaprojects, provides a snapshot of all epilepsy drugs in ongoing, clinical development that also have a special designation in the region listed. (Table 1) The majority of these drugs have both Orphan and Fast Track designation. Those with Fast Track designation are highlighted in orange.

 

 

Table 1. Epilepsy Drugs in Ongoing Trials with Orphan and/or Fast Track Designation

 

Epilepsy-blog-chart-2

Source: Trialtrove®and Pharmaprojects®, May 2015

 

 

SAGE-547’s inclusion here with fast track status, and the drug’s approved availability for an expanded access study, validates Sage’s claim of improved safety, attributed to specific allosteric modulation of the GABA pathway. Of interest, too, is that three of the other drugs with orphan designation are approved drugs reformulated for inhalation: diazepam (SK Corporation) and midazolam (Upsher-Smith) as nasal sprays and alprazolam (Alexza) for aerosolized delivery into the lungs. Certainly the new routes of administration for these drugs provide great examples of reformulation to optimize ease of administration for both the caregiver and the patient which is a continual challenge in epilepsy.

 

 

Trialtrove reveals only 15 industry-sponsored epilepsy trials focused on the treatment of status epilepticus. Two of these few trials, one each with brivaracetam and levetiracetam, were terminated due to poor enrollment. Difficulty with enrollment for SE is not surprising due to the nature of the condition. The FDA’s approval for Sage’s expanded access protocol is consistent with addressing this hurdle.

 

 

We will be keeping our finger on the pulse of SAGE-547 and anticipate catching you up with a comprehensive look at the horizon for Epilepsy in December with the Annual Meeting of American Epilepsy Society.

 

 

  1. Am Fam Physician 2003 Aug 1;68(3):469(http://www.aafp.org/afp/2003/0801/p469.pdf)

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