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Disease And Compound Specific Approaches To The Development Of Psychotherapeutic Agents

Disease And Compound Specific Approaches To The Development Of Psychotherapeutic Agents. Robert A. Leadbetter, MD Group Director, Neurosciences Medicines Development Center. Drug Development in Psychiatric Diseases. Issues:

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Disease And Compound Specific Approaches To The Development Of Psychotherapeutic Agents

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  1. Disease And Compound Specific Approaches To The Development Of Psychotherapeutic Agents Robert A. Leadbetter, MDGroup Director, Neurosciences Medicines Development Center

  2. Drug Development in Psychiatric Diseases • Issues: • Will a delay in filing to obtain long-term efficacy data be in the patient’s best interest? • How should long-term trials be designed to best examine chronic psychiatric illnesses? • Current practice: • NDAs are submitted based on acute efficacy data • Longer-term data is provided after NDA approval as new information to be included in product label • Position: • When and how long-term efficacy data are provided should be determined on a case-by-case basis

  3. Development of Psychotherapeutic Agents • Obtaining long-term data should account for differences In Disease Target And Compound Characteristics • Not All Psychiatric Disease States Require Long Term Treatment • Conversely, Some Treatments Can Target Only Long Term Intervention • Psychotherapeutic Drugs Differ in PK/PD Characteristics • These differences in treatment goals and product characteristics should influence when and how long-term data should be obtained • Study designs to generate longer-term efficacy data must differ based on disease state being studied “One size does not fit all”

  4. Not All Psychiatric Disease States Require Long Term Treatment • Acutely symptomatic patients may require psychopharmacologic intervention that would not be continued long-term • Acute bipolar depression with antidepressants • Short-term use of hypnotics for insomnia • Psychiatric disorders that generally do not require long-term treatment • Delirium • Brief reactive psychosis • Adjustment disorders

  5. Some Clinical Uses Target Primarily Long Term Intervention • Prevention (or delay) of future events • Lamotrigine for bipolar (acute efficacy has not been confirmed) • Anticonvulsants for seizure disorders • Beta-blockers for migraine • Chronic persistent or deteriorating symptoms – i.e. likelihood of spontaneous remission very low • Adult ADHD • Adjunctive Rx for cognitive impairment in schizophrenia

  6. Innate Differences in PK/PD Characteristics Necessitate Individualized Approaches • Pharmacodynamics • Benzodiazepines are associated with tolerance but other anxiolytics such as SSRIs are not • Future novel therapies may require different approaches to establishing long-term efficacy • Pharmacokinetics • Long ½ life agents may need different study designs

  7. Study Designs to Generate Longer-term Efficacy Data May Vary Per Disease Being Studied • Study design to generate longer-term efficacy data should be determined based on disease target and compound being studied • Randomized (PBO) withdrawal may not be appropriate • Study design should take into account known consequences of treatment interruption to the patient • In some diseases, the risk to the patient may outweigh the knowledge gained given symptoms will recur eventually if treatment is withheld, e.g. schizophrenia • There are limitations to the data obtained for the trial design proposed, e.g. generalizability

  8. Requiring Longer-term Efficacy Data At Time NDA Filing will Delay Availability of New Treatments to Patients • It is usually necessary to obtain fundamental information prior to institution of long-term efficacy studies • Some evidence of acute efficacy • Dose response relationship • Longer term open-label safety data • Data sufficient for IRB approval • The additional information gained with inclusion of longer-term efficacy data at NDA file must be weighed against the delay incurred in making new medications available to patients

  9. Summary • Differences in psychiatric disorders, treatment objectives, and compound characteristics necessitate an individualized approach for long-term efficacy requirements • Providing longer-term efficacy at time of NDA filing will incur a delay in the submission of the NDA • This time lost meeting this requirement needs to be weighed against the benefit of making new medications more quickly available to patients

  10. Requirement for Long-term Efficacy Data Needs To Consider Disease State And Compound Characteristics • Differences in the treatment objectives for the target disease state • Acute intervention • Preventative therapy • Chronic persistent/deteriorating symptoms • Differences in the drug profile • Pharmacokinetic characteristics • Mechanism of action “One size does not fit all”

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