Drug prohibition law

FDA Okays First Single-Entity Extended-Release Hydrocodone.

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The US Food and Drug Administration (FDA) has approved the first single-entity extended-release formulation of hydrocodone bitartrate (Zohydro ER, Zogenix Inc) for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.

“Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product,” a statement from FDA released today notes.

“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

This formulation belongs to the class of extended-release/long-acting (ER/LA) opioids, the statement notes. “Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the FDA release said.

It is not approved for as-needed pain relief.

In addition, the labeling approved for this drug conforms to updated labeling requirements for all ER/LA opioids announced by the FDA on September 10 and reported at that time by Medscape Medical News, the first opioid to be labeled in this way, the statement notes.

“The new class of labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications,” the FDA said. “These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices.”

Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record-keeping, reporting, and physical security requirements are also in place for these substances.

The FDA will require postmarketing studies of this agent to assess the “known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks,” the FDA release said. “These studies will also be required for other ER/LA opioid analgesics.”

Safety of this new formulation of hydrocodone is based on clinical studies that have included more than 1100 patients with chronic pain. Efficacy is based on a clinical study that enrolled more than 500 patients with chronic low back pain and showed a significant improvement in chronic pain vs placebo.

It will also be part of the ER/LA Opioids Analgesics risk evaluation and mitigation strategy (REMS) approved in 2012. The REMS requires companies to make educational programs on how to safety prescribe these agents to healthcare professionals and provide medication guides and patient counseling documents with information on safe use, storage, and disposal of ER/LA opioids.

The most common adverse effects of this single-entity hydrocodone are constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.

In December 2012, FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2, with 1 abstention, to recommended against approval of this agent for the treatment of moderate to severe chronic pain.

Most panel members voted that the drug had met regulatory requirements for safety and efficacy, as indicated by their responses to questions on efficacy and safety. However, for the last question voted on — “Based on the data presented and discussed today, do the efficacy, safety and risk-benefit profile of Zohydro ER support the approval of this application?” — most had negative responses.

The main concern of those voting against approval was that the potential for abuse of these agents; because the product does not include acetaminophen, they feared the potential for abuse might be even greater.

FDA Okays First Single-Entity Extended-Release Hydrocodone.

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The US Food and Drug Administration (FDA) has approved the first single-entity extended-release formulation of hydrocodone bitartrate (Zohydro ER, Zogenix Inc) for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.

“Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product,” a statement from FDA released today notes.

“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

This formulation belongs to the class of extended-release/long-acting (ER/LA) opioids, the statement notes. “Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the FDA release said.

It is not approved for as-needed pain relief.

In addition, the labeling approved for this drug conforms to updated labeling requirements for all ER/LA opioids announced by the FDA on September 10 and reported at that time by Medscape Medical News, the first opioid to be labeled in this way, the statement notes.

“The new class of labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications,” the FDA said. “These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices.”

Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record-keeping, reporting, and physical security requirements are also in place for these substances.

The FDA will require postmarketing studies of this agent to assess the “known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks,” the FDA release said. “These studies will also be required for other ER/LA opioid analgesics.”

Safety of this new formulation of hydrocodone is based on clinical studies that have included more than 1100 patients with chronic pain. Efficacy is based on a clinical study that enrolled more than 500 patients with chronic low back pain and showed a significant improvement in chronic pain vs placebo.

It will also be part of the ER/LA Opioids Analgesics risk evaluation and mitigation strategy (REMS) approved in 2012. The REMS requires companies to make educational programs on how to safety prescribe these agents to healthcare professionals and provide medication guides and patient counseling documents with information on safe use, storage, and disposal of ER/LA opioids.

The most common adverse effects of this single-entity hydrocodone are constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.

In December 2012, FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2, with 1 abstention, to recommended against approval of this agent for the treatment of moderate to severe chronic pain.

Most panel members voted that the drug had met regulatory requirements for safety and efficacy, as indicated by their responses to questions on efficacy and safety. However, for the last question voted on — “Based on the data presented and discussed today, do the efficacy, safety and risk-benefit profile of Zohydro ER support the approval of this application?” — most had negative responses.

The main concern of those voting against approval was that the potential for abuse of these agents; because the product does not include acetaminophen, they feared the potential for abuse might be even greater.

Source: Medscape.com

Use of ADHD drugs ‘increases by 50% in six years.

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There has been a 50% rise in England in the use of drugs for attention deficit hyperactivity disorder in six years.

NHS prescriptions for methylphenidate drugs, including Ritalin, rose from 420,000 in 2007 to 657,000 last year, the Care Quality Commission said.

The watchdog warned health workers to “carefully monitor” their use as they have the potential to be “abused”.

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The drugs are one of a number linked to the “smart-drug” craze, where students take medication to help them focus.

Methylphenidate is known as a psychostimulant.

While it is not completely clear how it works, it is thought to stimulate a part of the brain that changes mental and behavioural reactions.

The CQC report – its annual review of controlled drugs – said the number of prescriptions for both children and adults for such medications rose by 11% between 2011 and 2012.

Private prescribing also rose during the period going up from just under 2,000 in 2007 to just under 5,000 last year. But as the numbers of these are a small fraction of the NHS prescriptions the belief is that the rise has been driven by an increase in the number of ADHD diagnoses.

‘Worrying’ trend

The commission said: “As in previous years, we believe that this reflects increased diagnosis of, and prescribing for, the treatment of ADHD.

“We are also aware of the possibility that methylphenidate could be diverted and abused, and for this reason we recommend that its use should be monitored carefully.”

Consultant psychiatrist Professor Tim Kendall, who has compiled national guidelines on treating ADHD, told BBC Radio 4’s Today programme the increase in prescriptions was a worry.

 

He said: “I think it’s a real trend. I think it’s too big to be ignored.”

Asked if there are any dangers to people who take methylphenidate drugs over a long period, Prof Kendall said: “In children, without doubt. If you take Ritalin for a year, it’s likely to reduce your growth by about three-quarters of an inch.

“I think there’s also increasing evidence that it precipitates self-harming behaviour in children and in the long term we have absolutely no evidence that the use of of Ritalin reduces the long-term problems associated with ADHD.

“Having said that, if you’ve got a kid with severe ADHD, it’s very difficult to treat them psychologically without using Ritalin as well.”

Common symptoms of ADHD include inattentiveness, hyperactivity and impulsiveness. Symptoms tend to be first noticed at an early age and it is normally diagnosed between the ages of three and seven.

It is estimated that the condition affects 2% to 5% of school children and young people – although less than half of those have the severe form that requires medication. However, it can be a lifelong condition and many people continue to show symptoms in adulthood.

The CQC report also found there has been large increases in the use of other controlled drugs.

Methadone prescriptions in the NHS rose from 1.8m to 2.3m over six years, while buprenorphine, which like methadone is used as a pain relief, more than doubled to over 2.2m

However, use of temazepam, which is often used to sedate patients – the so-called chemical cosh, fell from 3.2m to 2.3m.

Source: BBC