Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Niacin · 2 trials · 1 indication
The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
| Arm | Type | Description |
|---|---|---|
| NER 500; ASA run-in, ASA coadmin | EXPERIMENTAL | Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks) |
| NER 500; ASA Pbo run-in, ASA coadmin | EXPERIMENTAL | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks) |
| NER 500; ASA Pbo run-in, ASA Pbo coadmin | EXPERIMENTAL | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks) |
| NER 1000; ASA run-in, ASA coadmin | EXPERIMENTAL | Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks) |
| NER 1000; ASA Pbo run-in, ASA coadmin | EXPERIMENTAL | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks) |
| NER 1000; ASA Pbo run-in, ASA Pbo coadmin | EXPERIMENTAL | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks) |
| NER/ASA | EXPERIMENTAL | - |
| NER/ASA Placebo | EXPERIMENTAL | - |
| NER Placebo/ASA Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| niacin extended-release (NER) | DRUG | Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period |
| aspirin (ASA) | DRUG | 325 mg tablets administered once daily |
| aspirin placebo (ASA Pbo) | DRUG | Tablets administered once daily |
| Niacin extended-release (NER) placebo | DRUG | Tablets administered once daily for 6 weeks |
| Aspirin (ASA) placebo | DRUG | Tablets administered once daily for 6 weeks |
Inclusion Criteria: * Subject must be 18 years of age or older. * If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide, Rosuvastatin |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | obicetrapib, ezetimibe daily |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
Niacin is used for dyslipidemia, a condition of abnormal lipid levels in the blood. It is being studied as an extended-release formulation, often combined with aspirin to manage flushing side effects. The drug is in Phase 3 clinical development for this cardiovascular indication.
Niacin is being developed by Abbott Laboratories, traded on the New York Stock Exchange under the ticker ABT. The company is conducting Phase 3 clinical trials for the drug in dyslipidemia.
Niacin is in Phase 3 clinical development for dyslipidemia. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been completed, with a total of 553 participants enrolled.
Niacin has two completed Phase 3 trials: NCT00626392, studying the effects of acetylsalicylic acid on Niaspan-induced flushing in 277 subjects, and NCT00630877, evaluating a flushing assessment tool in 276 subjects receiving niacin extended-release plus aspirin. Both were conducted in the United States.
Niacin is the active ingredient in the extended-release product Niaspan, which is the formulation used in the clinical trials. The trials specifically refer to Niaspan-induced flushing, indicating that Niaspan is a brand name for extended-release niacin.