Injectable XP-0863 for Acute Repetitive Seizures Given Fast Track Designation

Recently, specialty pharmaceutical company Xeris Pharmaceuticals (“Xeris”) announced that its injectable treatment XP-0863 received Fast Track designation for the treatment of patients with acute repetitive seizures. Xeris created this treatment using its proprietary XeriSol and XeriJect technologies. Through these, Xeris hopes to create easier to use (and more accessible) treatment options for those across the medical spectrum. Prior to receiving Fast Track designation, XP-0863 also received Orphan Drug designation for the treatment of Dravet syndrome and acute repetitive seizures.

XP-0863

Also known as a diazepam non-aqueous injection, XP-0863 is designed to treat patients with acute repetitive seizures, or cluster seizures. Drugs.com describes diazepam as:

a benzodiazepine [thought to work] by enhancing the activity of certain neurotransmitters in the brain. Diazepam is used to treat anxiety disorders, alcohol withdrawal symptoms, [muscle spasms, or] with other medications to treat seizures.

Currently, diazepam, under the name Diastat, is the only approved treatment option for patients with acute repetitive seizures. The FDA received data from a Phase 1b trial on XP-0863 and may allow Xeris to move into Phase 3 clinical trials for both adult and pediatric patients. For now, the FDA granted Fast Track designation to XP-0863. According to the FDA:
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Acute Repetitive Seizures

Also known as cluster seizures, acute repetitive seizures occur in patients with treatment-averse or difficult-to-control epilepsy. The Epilepsy Foundation defines acute repetitive seizures as:

a bout or cluster of seizures over a short period of time in which the patient regains consciousness between seizures.

Dr. Patricia Penovich, MD, who is part of the Epilepsy Foundation Minnesota Advisory Board, further clarifies that:

health care professionals use these terms to describe more than 2-3 seizures in 24 hours, or in some studies in 6-8 hours. Patients may identify different time periods that they recognize as specific to themselves.

Additionally, Dr. Penovich notes that cluster seizures frequently occur in patients with rare seizures or rare epilepsies. These seizures may be triggered by stress, alcohol or drugs, fever, or sleep deprivation. In many cases, patients with acute repetitive seizures do not respond well to medications. Finally, Dr. Penovich explains that patients with cluster seizures are much more likely to progress into status epilepticus, a medical emergency associated with nearly 55,000 fatalities each year.

Patients or family members should contact a doctor right away if experiencing any symptoms of status epilepticus, which include:

  • Non-stop seizures lasting 5+ minutes
  • Recurring seizures without becoming fully conscious
  • Clenched jaw
  • Grunting or other noises
  • Unusual breathing
  • Inability to speak
  • Blank facial affect
  • Lack of bladder and bowel control
  • Muscle spasms
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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