Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sufentanil NanoTabs and placebo NanoTabs · 1 trial · 2 indications
time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.
| Arm | Type | Description |
|---|---|---|
| Titration of sufentanil, the DBL sufentanil & PBO | EXPERIMENTAL | During the Titration Phase, patients titrated to the effective dosage of sublingual sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sublingual sufentanil NanoTab™ was taken as needed for breakthrough pain. During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active doses of sublingual sufentanil (dosage determined in Titration Phase) and three placebo doses taken in random order. One NanoTab™ was taken as needed for breakthrough pain. |
| Name | Type | Description |
|---|---|---|
| Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ | DRUG | During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage determined in the titration phase, and 3 doses of placebo. |
Inclusion Criteria: 1. Patients 18 years of age or older with documented clinical history or evidence of a malignancy. 2. Patients must have sufficient pain to require at least the equivalent of 60 mg/day oral morphine, at least 25 mcg/hr transdermal fentanyl, at least 30 mg/day oxycodone, at least...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Sufentanil NanoTabs and placebo NanoTabs were studied for the treatment of cancer breakthrough pain in adults. The Phase 2 trial enrolled patients with cancer and pain who were 18 years or older. The investigational product was compared with placebo NanoTabs to evaluate safety, tolerability, and efficacy in that setting.
Talphera, Inc., which trades under the ticker TLPH, is the developer of sufentanil NanoTabs and placebo NanoTabs. The company sponsored the clinical program evaluating the sublingual sufentanil NanoTab formulation against placebo NanoTabs in cancer breakthrough pain.
Sufentanil NanoTabs and placebo NanoTabs are in Phase 2 development. The single Phase 2 study, NCT00833040, has been completed. The drug is investigational and is not approved for commercial use. The completed trial enrolled 34 patients and evaluated safety, tolerability, and efficacy in cancer breakthrough pain.
Sufentanil NanoTabs and placebo NanoTabs were evaluated in one completed Phase 2 trial, NCT00833040, titled A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain. It was a randomized, double-blind study conducted in the United States with 34 enrolled patients.
Yes. Sufentanil NanoTabs and placebo NanoTabs are also known as sublingual sufentanil NanoTabs and placebo NanoTabs. The sublingual route describes how the NanoTab formulation is administered. The Phase 2 trial NCT00833040 evaluated this sublingual sufentanil NanoTab against placebo NanoTabs in cancer breakthrough pain.