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MHRA approves trial for new paracetamol poisoning treatment

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MHRA approves trial for new paracetamol poisoning treatment

PledPharma has recieved approval from the MHRA, the UK’s medicines regulatory body, to undertake a clinical trial for Aladote, a new treatment for reducing liver damage from paracetamol (acetaminophen) poisoning.

Paracetamol poisoning affects approximately 50,000 people the UK every year. The trial will evaluate the safety and tolerability of Aladote in combination with the current standard treatment (N-acetylcysteine) for the prevention of acute liver failure due to paracetamol poisoning. 


The clinical study will be conducted in collaboration with the University of Edinburgh under the direction of Dr James Dear, Reader in Pharmacology at the University of Edinburgh, and specialist in paracetamol poisoning. 


˝During the first 24 hours after paracetamol poisoning people usually experience few or no symptoms. Therefore, many patients come to hospital at such a late stage that the current standard treatment is not sufficient to prevent acute liver failure. I look forward to leading the evaluation of the drug candidate in this important proof-of-principle study,” Dear commented.

Paracetamol is the most commonly used drug in the world for the treatment of fever and pain, and is considered to be safe in therapeutic doses. However, toxic doses of more than four grams per day can cause severe, and sometimes fatal, liver damage. It is the drug most commonly taken in overdose in the UKii, and there are an estimated 50,000 emergency hospital admissions, and approximately 200 deaths, due to paracetamol poisoning in the UK every year. 

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