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Clinical Trials
Clinical Trials
The core mission of the Catalyst development program is to advance the treatment landscape for patients with rare, debilitating neuromuscular and neurological diseases.

Therapeutic areas of concentration

Lambert-Eaton Myasthenic Syndrome (LEMS)

Catalyst has completed two, phase 3 trials for amifampridine phosphate in the treatment of Lambert-Eaton myasthenic syndrome (LEMS). Both randomized trials resulted in positive, statistically significant data and in 2018 Catalyst will file a NDA for amifampridine phosphate for the treat
ment of LEMS. The FDA has assigned amifampridine phosphate as a “Breakthrough Therapy Designation” and an “Orphan Drug Designation” for LEMS.
For more information about the 1st LEMS trial, click here or go to clinicaltrials.gov.
For more information about the 2nd  LEMS trial, click here or go to clinicaltrials.gov.

MG-ADL=myasthenia gravis activities of daily living.

Access to Compassionate Use Programs

While information about the process for Compassionate Use program eligibility can be addressed to Catalyst by anyone, formal requests for Compassionate Use access to Catalyst products may only come from licensed prescribers. It is expected, though not guaranteed, that all such requests will be reviewed and a decision made within 30 days.

For more information about or to make a request for Compassionate Use access to Catalyst products, please contact Gary Ingenito at [email protected], or call 305-420-3223.

To review Catalyst’s Compassionate Use Policy, Click Here