Relypsa, Inc. (NASDAQ: RLYP) announced results from 12 Phase 1 studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa for oral suspension and 12 drugs that had previously demonstrated binding in in vitro tests. When Veltassa was administered at the same time as the drugs being tested, there was no clinically meaningful reduction in absorption for nine of the 12 drugs. Three drugs showed reduced absorption when they were co-administered with Veltassa, however, when dosing of Veltassa and these drugs was separated by three hours, no reduction in absorption was observed.
“The results from these studies are encouraging as, of the 12 drugs that had previously shown in vitro binding to Veltassa, nine showed no clinically meaningful reduction in absorption when co-administered with Veltassa in people,” said Lance Berman, M.D., chief medical officer of Relypsa. “In addition, when dosing was separated by three hours, there was no impact to absorption of the three drugs that had demonstrated reduced absorption when they were given with Veltassa. We look forward to discussing these data with the FDA and determining next steps.”
Summary of Veltassa Drug-Drug Interaction Program and ResultsVeltassa was approved by the U.S. Food and Drug Administration (FDA) on October 21, 2015, for the treatment of hyperkalemia, becoming the first new medicine in more than 50 years for people with elevated blood potassium levels.
The drug-drug interaction program submitted as part of Veltassa’s New Drug Application (NDA) included in vitro drug-drug interaction tests (conducted in test tubes).
As previously announced, in these initial in vitro tests, 14 of the 28 drugs showed no binding with Veltassa, including:
Fourteen drugs did show binding in vitro and, of these, 12 were selected for further testing in healthy volunteer studies to assess whether the results seen in vitro translated into an effect in people. These randomized, open-label studies were initiated in September 2015 and used a three-way cross-over design. They evaluated the absorption of these 12 drugs when either co-administered with Veltassa or when administered three hours apart from Veltassa. In each study, participants received:
For each drug tested, the studies evaluated the concentration in the blood over time (area under the curve or AUC) and the peak blood concentration (Cmax).
Results of Phase 1 In Vivo Studies
| Drugs | Veltassa and test drug administered at the same time | Veltassa administered three hours after test drug |
| Lithium (psychiatric medicine) | -- No clinically meaningful reduction in absorption (AUC) -- No impact on peak concentration (Cmax) | -- No impact on absorption (AUC) -- No impact on peak concentration (Cmax) |
| Trimethoprim (antibiotic) | ||
| Verapamil (antihypertensive) | ||
| Warfarin (anticoagulant) | ||
| Amlodipine (antihypertensive) | -- No clinically meaningful reduction in absorption (AUC) -- Some reduction in peak concentration (Cmax) | |
| Cinacalcet (calcimimetic) | ||
| Clopidogrel (antiplatelet) | ||
| Furosemide (diuretic) | ||
| Metoprolol (antihypertensive) | ||
| Ciprofloxacin (antibiotic) | -- Reduced absorption (AUC) -- Reduced peak concentration (Cmax) | |
| Levothyroxine (thyroid hormone replacement) | ||
| Metformin (antidiabetic) | ||
| Quinidine (antiarrhythmic) | -- Not tested in humans (quinidine rarely used; thiamine commonly present in food) | |
By: StreetInsider
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