Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EN3409 · 1 trial · 3 indications
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
| Arm | Type | Description |
|---|---|---|
| EN3409 | EXPERIMENTAL | Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily |
| Name | Type | Description |
|---|---|---|
| EN3409 | DRUG | Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily |
Inclusion Criteria: * Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year * Male subjects who are practicing abstinence, surgically sterile, or are using a m...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hinge Health, Inc. Class A | HNGE | 1 | N/A | Undisclosed |
| Stryker Corporation | SYK | 1 | - | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Aclarion, Inc. | ACON | 1 | - | Undisclosed |
| United Therapeutics Corporation | UTHR | 1 | N/A | Undisclosed |
| eHealth, Inc. | EHTH | 1 | N/A | Undisclosed |
EN3409 is an investigational small molecule being developed for the treatment of low back pain. It is also being studied for osteoarthritis and neuropathic pain. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
EN3409 is being developed by Collegium Pharmaceutical, Inc., a company traded on the NASDAQ under the ticker symbol COLL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for pain-related conditions.
EN3409 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The Phase 3 program includes a completed long-term open-label safety study, and the drug remains under clinical investigation.
EN3409 has one completed Phase 3 clinical trial registered under NCT01755546. This was a long-term open-label safety study that enrolled 304 participants with low back pain, osteoarthritis, or neuropathic pain. The trial was conducted in the United States and involved adults aged 18 years and older.
The completed clinical trial for EN3409, NCT01755546, was an uncontrolled, open-label study. It was not randomized and did not use a double-blind design. The study had no control group, meaning all participants received the investigational drug.