In two separate Phase 3 clinical trials, clinical studies conducted with patients. FIRDAPSE was tested against a placebo an inactive medication in adult patients with Lambert-Eaton myasthenic syndrome (LEMS).
The two Phase 3 studies were designed as withdrawal trials*:
*Withdrawal trials are used when researchers want to minimize the use of a placebo for ethical or feasibility reasons, and/or in situations where the efficacy can be determined immediately after patients stop taking the medication being studied.
RESULTS
The patients who started and stayed on FIRDAPSE:
† Measured by Quantitative Myasthenia Gravis (QMG) score, an objective assessment of arm strength, leg strength, face and neck muscle performance, swallowing, speech, grip strength, forced breathing, gaze impairment, and other measures.
‡ Measured by Subject Global Impression (SGI) score, a patient-reported outcome measure that shows how much they improved with FIRDAPSE compared to the placebo.
FIRDAPSE was evaluated in a separate test, the Triple-Timed Up-and-Go (3TUG), which measured how well FIRDAPSE improved the ability of LEMS patients to walk and move.
3TUG TEST
The 3TUG is a simple, timed test that requires the patient to stand up from a straight-backed armchair, walk 3 meters, turn around and walk back, and sit back down in the chair.
Individuals perform these actions 3 consecutive times without pause. The final measurement is the average time it takes the patient to complete all 3 repetitions.
RESULTS
The patients who received FIRDAPSE took significantly less time to complete the test compared to patients who received the placebo.
FIRDAPSE is a prescription medicine used to treat Lambert-Eaton myasthenic syndrome (LEMS) in people 6 years of age or older. It is not known if FIRDAPSE is safe or effective in children less than 6 years of age.
What is the most important information I should know about FIRDAPSE?
Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.
Do not take FIRDAPSE if you:
Before you take FIRDAPSE, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take FIRDAPSE?
What are the possible side effects of FIRDAPSE?
FIRDAPSE may cause serious side effects, including:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of FIRDAPSE.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FIRDAPSE?
Keep FIRDAPSE and all medicines out of the reach of children.
General Information about the safe and effective use of FIRDAPSE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FIRDAPSE for a condition for which it was not prescribed. Do not give FIRDAPSE to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about FIRDAPSE that is written for health professionals.
What are the ingredients in FIRDAPSE?
Please see full Prescribing Information for additional Important Safety Information.
FIRDAPSE is a prescription medicine used to treat Lambert-Eaton myasthenic syndrome (LEMS) in people 6 years of age or older. It is not known if FIRDAPSE is safe or effective in children less than 6 years of age.
What is the most important information I should know about FIRDAPSE?
Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.
Do not take FIRDAPSE if you:
Before you take FIRDAPSE, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take FIRDAPSE?
What are the possible side effects of FIRDAPSE?
FIRDAPSE may cause serious side effects, including:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of FIRDAPSE.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FIRDAPSE?
Keep FIRDAPSE and all medicines out of the reach of children.
General Information about the safe and effective use of FIRDAPSE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FIRDAPSE for a condition for which it was not prescribed. Do not give FIRDAPSE to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about FIRDAPSE that is written for health professionals.
What are the ingredients in FIRDAPSE?
Please see full Prescribing Information for additional Important Safety Information.