Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VEC-162 · 3 trials · 3 indications
Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.
The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.
Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.
| Arm | Type | Description |
|---|---|---|
| VEC-162 20 mg | EXPERIMENTAL | VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks |
| VEC-162 50 mg | EXPERIMENTAL | VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules PO daily five weeks |
| 20 mg VEC-162 | EXPERIMENTAL | 20 mg taken orally 30 minutes prior to bedtime. |
| 50 mg VEC-162 | EXPERIMENTAL | 50 mg taken orally 30 minutes prior to bedtime. |
| 100 mg VEC-162 | EXPERIMENTAL | 100 mg taken orally 30 minutes prior to bedtime. |
| Name | Type | Description |
|---|---|---|
| VEC-162 20 mg | DRUG | 20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks |
| Placebo | DRUG | Placebo capsules, PO daily for five weeks |
| VEC-162 50 mg | DRUG | 50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks |
| 20 mg VEC-162 | DRUG | 20 mg VEC-162 |
| 50 mg VEC-162 | DRUG | 50 mg VEC-162 |
| 100 mg VEC-162 | DRUG | 100 mg VEC-162 |
| VEC-162 | DRUG | - |
Inclusion Criteria: * Males and females with a diagnosis of primary insomnia as defined in DSM-IV. * Habitual bedtime between 9:00 pm and 1:00 am. * No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea. * Patients must sign a written consent form. Exclu...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan, Astra-Zeneca |
| ResMed Inc. | RMD | 1 | N/A | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | - | Daridorexant, Non-orexin receptor antagonist medications for insomnia |
VEC-162 is an investigational small molecule being developed for insomnia, circadian rhythm sleep disorders, and primary insomnia. It has been studied in healthy volunteers and in adult patients with primary insomnia. VEC-162 is not FDA approved and remains in clinical development.
VEC-162 is being developed by Vanda Pharmaceuticals Inc. (NASDAQ: VNDA). The company has conducted clinical trials of VEC-162 in the United States for insomnia and circadian rhythm sleep disorders.
VEC-162 has completed Phase 2 and Phase 3 clinical trials. It is an investigational drug and has not been approved by the FDA. The completed trials include a Phase 2 study in circadian rhythm sleep disorders and Phase 3 studies in insomnia and primary insomnia.
VEC-162 has completed three clinical trials: NCT00291187, a Phase 3 study in healthy adult volunteers in a model of insomnia with 411 participants; NCT00490945, a Phase 2 study on circadian rhythm in healthy volunteers with 45 participants; and NCT00548340, a Phase 3 study in adult patients with primary insomnia with 322 participants.
No alternative names for VEC-162 have been disclosed. It is referred to solely as VEC-162 in clinical trial records and by its developer, Vanda Pharmaceuticals.