Approval
The usual method of achieving approval for a drug is to show it is effective when compared against placebo, or that it is more effective than an existing drug. In monotherapy (where only one drug is taken) it is considered unethical by most to conduct a trial with placebo on a new drug of uncertain efficacy. This is because untreated epilepsy leaves the patient at significant risk of death. Therefore, almost all new epilepsy drugs are initially approved only as adjunctive (add-on) therapies. Patients whose epilepsy is currently uncontrolled by their medication (i.e., it is refractory to treatment) are selected to see if supplementing the medication with the new drug leads to an improvement in seizure control. Any reduction in the frequency of seizures is compared against a placebo. The lack of superiority over existing treatment, combined with lacking placebo-controlled trials, means that few modern drugs have earned FDA approval as initial monotherapy. In contrast, Europe only requires equivalence to existing treatments, and has approved many more. Despite their lack of FDA approval, the American Academy of Neurology and the American Epilepsy Society still recommend a number of these new drugs as initial monotherapy.
Read more about this topic: Anticonvulsant
Famous quotes containing the word approval:
“The approval of the public is to be avoided like the plague. It is absolutely essential to keep the public from entering if one wishes to avoid confusion. I must add that the public must be kept panting in expectation at the gate by a system of challenges and provocations.”
—André Breton (1896–1966)
“At the heart of the matter of masculine excess is a great longing for the love and approval of a father, a man who can tell another man that his masculinity is splendid enough and he can now relax.”
—Frank Pittman (20th century)
“Hardly a man in the world has an opinion upon morals, politics or religion which he got otherwise than through his associations and sympathies. Broadly speaking, there are none but corn-pone opinions. And broadly speaking, Corn-Pone stands for Self- Approval. Self-approval is acquired mainly from the approval of other people. The result is Conformity.”
—Mark Twain [Samuel Langhorne Clemens] (1835–1910)