Nimodipine

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
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Articles

Medicine Compliance Aid Stability

NimotopBayer plc

Bayer plc
Nimotop
Tablets f/c 30mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Nimodipine is light sensitive
9 November 2015

Lactation Safety Information

-
Very limited published evidence of safety
Only negligible amounts in breast milk
Used in infants >1 month
16 January 2017

New Medicines

Aneurysmal subarachnoid haemorrhage (SAH)

Information

New formulation
PDS Biotechnology Corporation
PDS Biotechnology Corporation

Development and Regulatory status

Suspended
Suspended
Suspended
Yes
Yes
Oct 19PDS is actively looking to license out EG-1962 and has had preliminary discussions with third parties who are looking at the data of EG-1962. Not listed in PDS pipeline and all development was ceased by Edge [7].
Mar 19PDS Biotechnology Corporation merges with Edge Therapeutics to form PDS Biotechnology Corporation [6].
Mar 18Edge has decided to discontinue the NEWTON 2 study. Development suspended whilst Edge carry out analyses of the cumulative unblinded data from the NEWTON 2 study to better understand the basis for the outcome.[5]

Category

A single-dose, proprietary bioabsorbable formulation of the calcium channel blocker, nimodipine.
SAH affects 6-9 people per 100,000 of the population per year and constitutes about 6% of first strokes. Approximately 85% of patients bleed from intracranial arterial aneurysms, 10% from a non-aneurysmal peri-mesencephalic haemorrhage and 5% from other vascular abnormalities including arteriovenous malformation, vasculitis and abnormal blood vessels associated with tumour [1].
Aneurysmal subarachnoid haemorrhage (SAH)
Intracranial

Trial or other data

Mar 18Interim analysis performed on data from the day 90 visit of the first 210 pts with Aneurysmal SAH who were randomised and treated in the PIII NEWTON 2 study, suggests the study is unlikely to achieve its primary efficacy endpoint. Although there were no safety concerns attributed to EG-1962, the independent Data Monitoring Committee (DMC) recommended that the study be stopped because it has a low probability of achieving a statistically-significant difference compared to the standard of care in the study’s primary endpoint, if the study is fully enrolled.[5]