Calmare Therapeutics Inc (fka CTTC)

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http://www.painnewsnetwork.org/stories/2016/1/30/lyrica-and-neurontin-face-uk-restrictions

Lyrica and Neurontin Face UK Restrictions
January 31, 2016
By Pat Anson, Editor

Two drugs often recommended as safer alternatives to opioid pain medication could face new restrictions in the UK because of increasing reports they are being abused.

British health officials say the prescription drugs pregabalin and gabapentin, which are sold by Pfizer under the brand names Lyrica and Neurontin, are being used by drug abusers to get high, resulting in dozens of overdose deaths.
Since 2012, at least 38 deaths involving pregabalin and 26 involving gabapentin have been reported in the UK.

The prescribing of pregabalin and gabapentin in the UK has soared by 350% and 150%, respectively, in the last five years. Both medications are anti-seizure drugs widely prescribed to treat epilepsy, neuropathy, fibromyalgia and anxiety.

The UK Advisory Council on the Misuse of Drugs (ACMD) is recommending that gabapentin (Neurontin) and pregabalin (Lyrica) be reclassified as Class C controlled substances – which would mean prescriptions would only be valid for one month and there can be no refills.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin may have a higher abuse potential than gabapentin due to its rapid absorption and faster onset of action and higher potency. Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

The letter warns there is a risk of addiction for both drugs, as well as misuse and diversion.

“The use of gabapentin and pregabalin by the opioid abusing population either together or when opioids are unavailable reinforces the behavior patterns of this high-risk population. There is a high risk of criminal behavior stimulated by the wish to obtain gabapentin and pregabalin,” said Iverson.

Lyrica is Pfizer’s top selling drug and generates worldwide sales of over $5 billion annually. Pfizer said the recommendation to reclassify the drugs and limit their prescribing could be harmful to patients.

“We are concerned that the advice contains a number of inaccuracies and some potentially misleading information, and is contrary to the totality of the safety data available for pregabalin and gabapentin,” the company said in a statement reported on the Pulse website. “Controlling the supply of these products across the whole UK, would be a disproportionate measure that would impact on patients and their quality of life, and could also result in additional economic and operational burden on an already strained healthcare system.”

Earlier this month a study of 440 drug abusers in Ireland found that 39 tested positive for pregabalin in their urine. Only ten of them had been prescribed the drug. Other drugs detected in pregabalin positive patients were opiates, cocaine, benzodiazepine and cannabis, according to the Irish Examiner.

The study called the abuse of pregabalin a “serious emerging issue.” Recreational users of pregabalin in Belfast call the drug “Budweisers” because it induces a state similar to drunkenness.

Neurontin (gabapentin) is approved by the FDA to treat epilepsy and neuropathic pain, but is widely prescribed “off-label” for a variety of other conditions, including depression, migraines, fibromyalgia and bipolar disorder. In 1999 a Pfizer executive was so mystified by Neurontin’s growing use he called it the “snake oil of the twentieth century.”