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VX-150 · 6 trials · 4 indications
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to VX-150 for 2 days. |
| VX-150 - Dose Level 1 | EXPERIMENTAL | Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days. |
| VX-150 - Dose Level 2 | EXPERIMENTAL | Participants received VX-150 1000 mg once daily (qd) for 2 days. |
| VX-150 - Dose Level 3 | EXPERIMENTAL | Participants received VX-150 500 mg q12h for 2 days. |
| VX-150 - Dose Level 4 | EXPERIMENTAL | Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days. |
| VX-150 - Dose Level 5 | EXPERIMENTAL | Participants received VX-150 250 mg qd for 2 days. |
| VX-150 | EXPERIMENTAL | - |
| Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | - |
| VX-150, placebo | EXPERIMENTAL | Sequence 1: VX-150 in Treatment Period 1→washout→ placebo in Treatment Period 2 |
| placebo, VX-150 | EXPERIMENTAL | Sequence 2: placebo in Treatment Period 1→washout→ VX-150 in Treatment Period 2 |
| VX-548 | EXPERIMENTAL | Participants will be randomized to receive a single dose of different dose levels of VX-548 |
| VX-993 | EXPERIMENTAL | Participants will be randomized to receive a single dose of different dose levels of VX-993. |
| Name | Type | Description |
|---|---|---|
| VX-150 | DRUG | Capsules for oral administration. |
| Placebo | DRUG | Capsules for oral administration. |
| HB/APAP | DRUG | Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days. |
| VX-548 | DRUG | Solution or suspension for oral administration. |
| VX-993 | DRUG | Suspension for oral administration. |
Key Inclusion Criteria: Before surgery: * Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m\^2) * Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not t...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
VX-150 is an investigational oral small molecule developed by Vertex Pharmaceuticals for the treatment of pain. It has been studied in acute pain, osteoarthritis, pain generally, and small fiber neuropathy. It is a Phase 2 clinical candidate and has not been approved by the FDA.
VX-150 targets NaV1.8, a voltage-gated sodium ion channel. NaV1.8 is expressed in peripheral sensory neurons and is involved in transmitting pain signals. By inhibiting this ion channel, VX-150 is designed to reduce pain signaling.
VX-150 is developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex is the sponsor of the clinical program evaluating VX-150 across pain indications.
VX-150 is in Phase 2 clinical development. It is investigational and has not received FDA approval. The Phase 2 studies in acute pain following bunionectomy and in small fiber neuropathy have both been completed.
VX-150 has been evaluated in completed trials including NCT03764072, a Phase 2 dose-ranging study in acute pain following bunionectomy with 250 participants, and NCT03304522, a Phase 2 study in small fiber neuropathy with 89 participants. Earlier Phase 1 microneurography studies include NCT05418712 and NCT06420765.
VX-150 has been studied for pain, including acute pain following bunionectomy, osteoarthritis, and small fiber neuropathy. These are the indications explored in its clinical program, and the drug remains investigational rather than approved for any use.