Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication NEURONTIN ® is indicated for: • Management of postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for: • Postherpetic neuralgia in adults ( 1 ) • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary…
Gabapentin · 10 trials · 3 indications
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.
Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds \[sec\]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of "no pain" (0) to "maximum pain" (100) at the anchor endpoints of the scale and "moderate pain" at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec.
Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.
| Arm | Type | Description |
|---|---|---|
| gabapentin | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Gabapentin 250 mg | EXPERIMENTAL | - |
| Gabapentin 500 mg | EXPERIMENTAL | - |
| Gabapentin 1200mg | ACTIVE_COMPARATOR | - |
| Diphenhydramine 50 mg | ACTIVE_COMPARATOR | - |
| Morphine 10 mg | ACTIVE_COMPARATOR | - |
| Placebo formulations | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| gabapentin | DRUG | Orally administered gabapentin |
| Placebo | DRUG | Matched placebo oral capsule 30 minutes prior to bedtime |
| Diphenhydramine | DRUG | Tablet, single 50mg dose |
| Morphine | DRUG | IV, single 10mg dose |
Inclusion Criteria: * Completion of study A9451162 (NCT00603473) Exclusion Criteria: * Seizures related to drugs or acute medical illness * History of any serious medical or psychiatric disorder
Gabapentin is being studied for partial epilepsies and transient insomnia. It is a small molecule neurology asset developed by Pfizer, Inc. (NYSE: PFE). The transient insomnia program has reached Phase 3, while the epilepsy program also sits at Phase 3 in the development record.
Gabapentin targets the calcium channel subunits CACNA1H, CACNA2D1, CACNA1C, CACNA2D3, CACNA1S, and CACNA2D2. It acts as a modulator at these targets, which are voltage-gated calcium channel components. This target profile places gabapentin among small molecule modulators of calcium channel signaling in neurology.
Gabapentin is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor behind the clinical program covering partial epilepsies and transient insomnia.
Gabapentin is in Phase 3 development. The program includes Phase 3 trials in transient insomnia and a Phase 1 study in healthy male volunteers. It is an investigational asset in clinical development and is not described as approved for these indications.
Gabapentin has been studied across eight trials, including NCT00674752, a Phase 3 polysomnographic study in transient insomnia with 377 participants, and NCT00667108 and NCT00666939, Phase 3 transient insomnia studies with 784 and 773 participants. NCT01119222 was a Phase 1 cold pain study in 19 healthy male volunteers in Belgium.
Across the eight gabapentin trials, total enrollment is 5,877 participants. Two trials are completed, and the largest completed studies are the Phase 3 transient insomnia trials conducted in the United States. The trials were uncontrolled, without randomization or double blinding.