A phase 3 study assessing the use pregabalin as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint to reduce seizure frequency compared with placebo, according to Pfizer.

The 12-week randomized, double-blind, placebo-controlled, multicenter study was conducted at 70 sites in 21 countries and included 219 patients. Patients were randomized in a 1:1:1 ratio to receive placebo, or 1 of 2 fixed doses of pregabalin twice daily. The primary endpoint was the percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo.

Findings from the phase 3 study showed that treatment with pregabalin for PGTC seizures did not result in a statistically significant reduction in seizure frequency versus placebo.

A prescription drug linked to 33 deaths in 2017 in Northern Ireland will now be treated as a class C drug.

Pregabalin – also known by the brand name Lyrica, or the street name bud – is an anti-epileptic drug also used to relieve chronic pain.

Northern Ireland has the highest prescription rate for pregabalin in the UK.

It is illegal to have class C drugs without a prescription and illegal to supply or sell them to others.

Meanwhile the mother of a man who took his own life, speaks about her son’s struggle with addiction to prescription drugs.

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There will also be stronger controls in place to ensure accountability and minimise the chances of pregabalin falling into the wrong hands or being stockpiled by patients.

Deaths relating to the prescription drug are on the rise.

In 2016 eight drug deaths were linked to Lyrica misuse – one year later that figure rose to 33.

The Advisory Council for the Misuse of Drugs made the recommendation to reclassify the drug in a letter to ministers, including the then home secretary Theresa May, in January 2016.

The letter cited warnings from the Health and Social Care Board (HSCB), which highlighted “significant misuse and abuse” of the drug.

Where are the drugs coming from?

There is a growing illicit market for the drug in Northern Ireland, with many people purchasing it online from unregulated websites.

It is understood that Lyrica has been coming into Northern Ireland in fairly constant levels for a number of years, along with other prescription drugs including diazepam and temazepam.

Packages of the drug ordered by customers in Northern Ireland are intercepted by the National Crime Agency (NCA) and the UK Border Agency at airports in England every week, according to the Police Service of Northern Ireland (PSNI).

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While the drugs are referred to as prescription drugs, they are largely not being prescribed through community pharmacies.

They are illicitly bought or sold and supplied through the internet and largely the individuals are appearing to be using a mixture of drugs.

Joe Brogan, the HSCB’s head of pharmacy and medicines management, described the growing numbers of deaths associated with pregabalin and other prescription drugs as a “scourge”.

He added: “In many cases of pregabalin misuse, it has not been prescribed – it has been sourced through family or friends or bought on the street or via the internet.

“Many such drugs that are bought from illicit sources do not actually contain medicines that they purport to be.

“Any medicine or any drug can be a poison – it all depends on three things: Where you get it from – was it prescribed and supplied from a regulated source?; how much you take – was it taken within accepted dosages?; what you take it with – mixing drugs together and with alcohol can create a toxic mix that is lethal.”