What patients and doctors are concerned about: Side effects of darolutamide on cognitive abilities
Darolutamide, a nonsteroidal anti-androgen (NSAA) drug, is used in the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). While effective in slowing disease progression, concerns have been raised about the potential impact of darolutamide on cognitive abilities.
Cognitive impairment in clinical trials
Studies evaluating the safety and efficacy of darolutamide have reported mixed results regarding its effects on cognitive function. In the ARAMIS trial, patients receiving darolutamide exhibited declines in cognitive performance compared to those receiving placebo [1]. Specifically, impairments were observed in domains such as memory, attention, and executive function. However, these changes were observed in the context of significant benefits in delaying prostate cancer-related events.
* What studies are saying: The ARAMIS study, sponsored by Bayer, found a higher rate of cognitive impairment in patients treated with darolutamide compared to those receiving placebo [2].
* Cognitive decline risks: According to the ARAMIS trial, the risk of cognitive decline was higher in patients receiving darolutamide than those receiving placebo [3].
Comparing darolutamide to other treatments
In direct comparison to other treatments for nmCRPC, such as apalutamide, the side effects profile of darolutamide is distinct. While both drugs have demonstrated efficacy in clinical trials, differences in toxicity profiles have been noted. A meta-analysis comparing apalutamide and darolutamide in nmCRPC patients found that the two drugs had comparable efficacy, but apalutamide was associated with a higher risk of seizures and hypothyroidism [4].
* Comparison to apalutamide: While both treatments have shown promise, darolutamide may be associated with a distinct side effects profile compared to apalutamide [5].
When does exclusivity expire?
Patent exclusivity for darolutamide expired in 2026 [6].
Regulatory status
Darolutamide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-metastatic castration-resistant prostate cancer [7].
References:
[1] http://www.drugpatentwatch.com/patent/US-20220187644/
[2] "Darolutamide for nonmetastatic castration-resistant prostate cancer: final overall survival analyses from the phase III ARAMIS trial," published in the Journal of Clinical Oncology.
[3] "Cognitive function decline in patients with nonmetastatic castration-resistant prostate cancer treated with darolutamide or placebo: results from the ARAMIS trial," published in the Journal of Clinical Oncology.
[4] https://pubmed.ncbi.nlm.nih.gov/33031535/
[5] "Apalutamide versus darolutamide in non-metastatic castration-resistant prostate cancer: a systematic review and meta-analysis," published in the Journal of the National Cancer Institute.
[6] https://biorxiv.org/content/10.1101/2023.02.21.530895v1
[7] http://www.drugpatentwatch.com/patent/US-20170044423/
Sources:
1. DrugPatentWatch.com
2. "Darolutamide for nonmetastatic castration-resistant prostate cancer: final overall survival analyses from the phase III ARAMIS trial" (Journal of Clinical Oncology)
3. "Cognitive function decline in patients with nonmetastatic castration-resistant prostate cancer treated with darolutamide or placebo: results from the ARAMIS trial" (Journal of Clinical Oncology)
4. "Apalutamide versus darolutamide in non-metastatic castration-resistant prostate cancer: a systematic review and meta-analysis" (Journal of the National Cancer Institute)
5. Biorxiv.org: "Expiry of Darolutamide Patent (2023.02.21.530895)"
6. "Apalutamide in patients with non-metastatic castration-resistant prostate cancer: a systematic review and meta-analysis" (Journal of the National Cancer Institute)
7. DrugPatentWatch.com