World's first 3D printed therapy gets FDA okay

by IainBate 6. August 2015 10:48

The US Food and Drug Administration has approved Aprecia Pharmaceuticals Co’s epilepsy treatment Spritam, the world’s first 3D printed drug.

Spritam (levetiracetam) is made with Aprecia’s ZipDose technology which uses three-dimensional printing to produce a porous formulation that rapidly disintegrates with  a  sip  of  liquid. This system allows for higher dosage into a tablet – up to 1,000mg – and chief executive Don Wetherhold said Spritam is designed to fill a need for patients who struggle with their current medication experience.

He added that “this is the first in a line of central nervous system products Aprecia plans to introduce”. Although the FDA has previously approved 3D-printed medical devices, this is the first time a 3D-printed product has been given the green light.

Spritam is expected to be available in the first quarter of 2016.

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Time Machine

by Admin 2. October 2013 09:47

The third in our series on diseases that have impacted on social history and culture – and how medicines have enabled us to fight them.

Famous people

People known to have su†ffered from epilepsy include ‘nonsense’ poet Edward Lear, novelist Fyodor Dostoyevsky, comic actor Bud Abbott (who masked the symptoms with the more socially acceptable state of drunkenness) and singer Ian Curtis of Joy Division. Living musicians who have (or have had) epilepsy include Prince, Neil Young, Mike Skinner, Lil Wayne and Richard Jobson. Politician Tony Coelho, who developed epilepsy following a head injury in his teens, was a Democrat congressman for many years. During Coelho’s first election campaign, his opponent asked the press how people would feel if Coelho had a seizure at the White House. Coelho commented: “Well, in the 13 years I have served in Washington I knew a lot of people who went to the White House and had fits. At least I’d have an excuse.”

Disease

Epilepsy is a neurological disorder characterised by recurrent seizures. There are more than a dozen common types of epilepsy with di†fferent patterns of symptoms. A traditional distinction is made between petit mal or ‘absence seizures’ (which are brief and passive) and grand mal or tonic-clonic seizures (which are violent and protracted). Epilepsy a†ffects up to 5% of the population at some time in their lives, with 3% of people in the UK being diagnosed with the condition. It is usually caused by brain injury or other trauma, but can have genetic causes. In some patients, seizures can be triggered by • ashing lights or other forms of ‘sensory overload’. People usually recover from epilepsy after some years, but it can cause death through injury or lead to suicide. A persistent seizure or status epilepticus can be fatal, but is rare.

History

Epileptic seizures were considered ‘divine’ by the Greeks, and have been speculatively linked to ‘visionary’ experiences. However, they were also considered evidence of ‘demonic possession’ by the Catholic Church and treated with ‘exorcism’ rituals, a form of torture that was usually fatal. Jean-Martin Charcot, considered the founder of modern neurology, saw people with epilepsy con ned among the ‘incurably insane’ inmates of the Saltpêtrière institution in Paris in the late 19th century. …The word ‘lunatic’ derives from the Greek word for people with epilepsy, as their seizures were believed to be a†ffected by the moon – a belief possibly inspired by the incidence in some women of seizures linked to the menstrual cycle.

Culture

…The association of fits with visionary states is a recurrent theme in mystical and Gothic literature. Regrettably, the ‘possession’ myth has been exploited by commercial horror films, often made from a religious perspective and featuring stereotypes such as the foulmouthed adolescent girl in The Exorcist. The Joy Division song ‘She’s Lost Control’ described a grand mal seizure in bleakly sympathetic terms, contrasting the helplessness of a seizure with the myths and the lies of normal life.

Future

According to a NICE audit, epilepsy causes about 1,000 deaths each year in the UK, and 42% of these are avoidable. Revised NICE guidance issued in January 2012 aimed to give doctors a wider range of choices, outlining how and when treatment for di†fferent types of epilepsy should be provided. Reduction in medication side-e†ffects continues to be a high priority, as does developing an e†ffective medication for the 30% of patients who do not respond to current therapies. Medical education to overcome the stigmatisation of people with epilepsy remains vital.

Treatment

Epilepsy is normally treated with anticonvulsant drugs, taken daily. Over 20 such drugs are in use in the UK, including Tegretol (carbepamazine), Rivotril (clonazepam), Lamictal (lamotrogine) and Epilim (sodium valproate). …These tend to have sedative or tranquillising properties. Side-e†ffects commonly include persistent tiredness, weakness, nausea, dizziness and energy loss. Drug adherence is a major issue in the treatment of epilepsy, as patients may prefer the risk of seizures to constant side-e†ffects. Other forms of treatment include brain surgery, electrical stimulation (e.g. of the vagus nerve), avoidance of sensory triggers and psychological therapies.

 

 

 

 

Eisai’s UK site to export to US

by JoelLane 11. September 2013 17:55

Gary Hendler, Eisai (web) Eisai’s EMEA Knowledge Centre, based in Hatfield, has been approved by the FDA as the source for the US supply of epilepsy drug Fycompa (perampanel).

The Hatfield site will manufacture six different tablet strengths of the drug, a leading epilepsy treatment, for the US market.

The FDA approval reflects the growing investment of Japanese company Eisai in the UK as a global drug manufacturing base – and also an R&D base, since Fycompa was jointly developed by the UK and Japanese operations.

Gary Hendler, CEO of Eisai EMEA, said: “The FDA approval for the supply of our epilepsy drug perampanel is testament to the commitment we have made at our EMEA Knowledge Centre and the Hatfield manufacturing facility.

“The UK is a competitive location for advanced manufacturing and packaging and I am delighted that we are now able to export products developed and manufactured here in the UK to the US.”

Eisai established the £100m EMEA Knowledge Centre at Hatfield, Hertfordshire, in June 2009 to integrate the company’s R&D, production, marketing and EMEA headquarters functions.

Fycompa, approved as an adjunctive treatment for partial onset seizures, is one of four anti-epilepsy drugs marketed by Eisai in the EMEA region.

Eisai EMEA has sales operations in over 20 countries, including the UK.

Ranbaxy pays $500m to settle FDA fraud charges

by JoelLane 31. May 2013 16:40

Ranbaxy Indian generics giant Ranbaxy has agreed to pay a $500m fine to settle FDA charges of fraud – covering unsafe practices – at two of its factories.

The fine, the largest ever paid by a generic drug manufacturer in the US, comprises $150m for criminal charges and $350m for civil claims.

The offences relate to documents submitted to the Medicare and Medicaid programmes between 2003 and 2010, which Ranbaxy acknowledges made false claims regarding certain products.

FDA inspectors found that drugs manufactured at two Ranbaxy factories in India did not meet safety requirements.

The generic drugs in question included an acne drug (isotretinoin), an epilepsy and nerve pain drug (gabapentin) and antibiotics including amoxicillin.

Ranbaxy manufactured, distributed and sold these drugs when their strength, purity or quality was not that specified by the product literature or the FDA’s approved formulation.

The company acknowledged that inspections of its factories had found evidence of inadequate product testing and record-keeping, as well as deviations from good manufacturing practice.

It also admitted making “false, fictitious and fraudulent” statements to the FDA in annual reports filed in 2006 and 2007 regarding the dates of stability tests conducted on antibiotics.

In 2008, the FDA banned Ranbaxy from selling about 30 drugs in the US. In 2009, it halted reviews of certain Ranbaxy products.

Ranbaxy’s former owners, the family who founded it, have repudiated what it claims are implicit accusations of corruption levelled at it by the company’s present management.

Dinesh Thakur, Ranbaxy’s former Global Head of Research Information and Portfolio Management, will receive $48.6m of the settlement as a whistleblower.

Medicine shortages reach ‘tragic point’ in Greece

by JoelLane 1. March 2013 12:30

greece Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

SMC approves epilepsy drug

by JoelLane 10. December 2012 16:19

epilepsy The Scottish Medicines Consortium (SMC) has approved Fycompa (perampanel) for use as an adjunctive treatment in hard to treat cases of epilepsy.

Eisai’s drug is recommended as an additional second-line therapy for partial-onset epilepsy, the most common form of the disease, in people aged 12 and over.

Its approval adds to the armoury of drugs available to treat uncontrolled partial seizures, which have a severe impact on quality of life.

The incidence of uncontrolled partial seizures is high (20–40%) despite the wide range of anti-epileptic drugs available.

The number of people with epilepsy in Scotland has increased by 40% in six years to 54,000, indicating an urgent need for better medical solutions.

Fycompa is a first in class drug: the only licensed AED in Europe that targets the neurological receptors thought to play a central role in seizures. It blocks their response to glutamate, an excitatory neurotransmitter.

In addition, Fycompa has the benefit of convenient, once-daily dosing.

The licensing of the drug by the European Commission was based on three global Phase III studies with 1,480 subjects, which demonstrated its efficacy and tolerability as an adjunctive therapy.

“This approval from the SMC is a positive step in the management of people with epilepsy in Scotland,” said Martin Brodie, Professor of Medicine and Clinical Pharmacology at the University of Glasgow.

“Uncontrolled seizures have a severe impact on everyday function and quality of life and so we look forward to the possibility of being able to offer our epilepsy patients a new treatment option.”

Nick Burgin, Director Market Access, Eisai EMEA & Russia, commented: “This is the first health technology approval in Europe [for Fycompa] and demonstrates the SMC’s commitment to giving patients access to innovative medicines.”

Authorities back child-friendly epilepsy drug

by IainBate 19. November 2012 12:19

Inovelon - web Eisai is celebrating after The All Wales Strategic Medical Group (AWSMG) and Scottish Medicines Consortium (SMC) backed a drinkable version of Inovelon (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

The oral suspension can be used in children aged four and over who have failed treatment with, or are intolerant of, other antiepileptic drugs.

Mike Bee, Epilepsy Business Unit Director, EU North, Eisai, said approval of the medication was important to “help address the adherence needs of children and young people.”

LGS is a severe form of epilepsy which accounts for between 5%-10% of childhood cases.

The decision to approve the treatment follows the approval of the tablet formulation by both authorities in 2008. That approval was based on data which showed Inovelon can significantly reduce the frequency of total and tonic-atonic seizures and improve seizure severity.

The oral alternative was shown to be bioequivalent and cost-effective in Scotland and Wales.

Inovelon – in an oral form – received positive CHMP opinion in September last year and was granted EMA approval in November 2011. It was launched in the US in March 2011 marketed as Banzel.

Neurological patients neglected by NHS, report says

by IainBate 2. August 2012 16:34

Neurological patients neglected by NHS, report says - Pharmaceutical Field Sub-standard primary care treatment for people with neurological conditions is resulting in a high number of emergency hospital admissions, a new report has said.

A report by the Neurological Alliance accuses the NHS of neglecting patients through delays in diagnosis and failure to provide information on treatment options.

The Alliance said that the NHS reforms would not improve standards of care due to levers “not being mobilised to support improvements”.

The report called for the new bodies created as part of the Health and Social Care Act to address the “legacy of neglect” that has resulted in “unacceptable variations in outcomes and higher than necessary costs”.

Neurological conditions, such as epilepsy and multiple sclerosis, account for 5% of overall spending on the NHS.

The DH and the NHS Commissioning Board have now been challenged by the Alliance to devise indicators for quality of service that will overhaul and improve standards of care.

The DH said that discussions were already taking place to ensure that strategic clinical networks cover these conditions. “We are working closely with patient groups and health professionals to develop a new Long-Term Conditions Strategy,” said a spokesperson. “The NHS Commissioning Board is already planning to drive improvements to improve mental health services, dementia and neurological conditions.”

The Neurological Alliance is formed by 70 charities that work with people with related brain, spinal column or nerve conditions.

Scottish NHS in partnership for epilepsy care

by JoelLane 29. June 2012 11:28

Dumfries_and_Galloway Epilepsy patients in Dumfries and Galloway will benefit from a unique partnership between the Scottish NHS, pharmaceutical companies and the voluntary sector.

The cross-sector collaboration will deliver specialist nurse training for local health professionals to develop their expertise in managing epilepsy across all care environments.

NHS Dumfries and Galloway will work with charity Epilepsy Scotland and pharma companies Eisai, GSK and UCB Pharma to develop the service.

Epilepsy, which affects over 1,500 people in the region, poses challenges to both primary and secondary care: medication is often poorly tolerated and acute episodes are dangerous.

Epilepsy Scotland will provide a specialist nurse for three days a week to ‘upskill’ health professionals, while the three pharma companies will support the training with software, printing and other resources.

The partnership will run for three years and, according to Epilepsy Scotland Chief Executive Lesslie Young, will create “a legacy of epilepsy care in this area”.

It will enable the region’s NHS Board to address an identified lack of expertise, and to provide services directly that it had previously outsourced.

Young commented that the project is “an original model of cascading epilepsy expertise” that “sets a new benchmark in joint working” towards the shared goal of “better patient-centred treatment”.

“This innovative proposal allows the research-led pharmaceutical industry to work with our partners to improve the delivery of healthcare and focus on improving outcomes for patients at a time of significant financial challenge,” noted Gordon Lundie, UCB’s Government Affairs & Market Access Director.

Jeff Ace, Chief Executive of NHS Dumfries and Galloway, said the project was “a milestone collaboration”.

New child-friendly epilepsy drug launched in Europe

by JoelLane 15. March 2012 10:49

Pf product news A drinkable formulation of a drug for a rare childhood-onset form of epilepsy has been launched in Europe for the first time.

Inovelon (rufinamide) oral suspension from Eisai Europe is now available in Germany for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children aged four and older.

The orphan drug’s new formulation is a step forward in addressing the issue of medication adherence in young people with epilepsy.

LGS is a severe, debilitating form of epilepsy that accounts for 10% of all childhood cases, affecting 2.8 children in every 10,000 in Europe.

Medication compliance is of crucial importance in the treatment of LGS, as the condition – which most often appears between the ages of two and seven – causes multiple daily seizures leading to mental retardation.

Inovelon, which is thought to regulate electrical charges in the brain, was approved in tablet form for adjunctive treatment of LGS in Europe in 2007 and is now available in 19 European countries.

The new suspension formulation has been launched in Germany and will shortly become available in Austria, followed by other EU countries. It received EMA marketing approval in November 2011, and has been available in the US (as Banzel) since March 2011.

Dr Thomas Bast, Head of the Department of Children and Adolescents, Epilepsy Centre Kork, Kehl, Germany, said: “As some children might find conventional tablets difficult to swallow, there is a strong need for drinkable medicines especially when treating younger epilepsy patients. In addition, administration of suspension allows for individual titration in smaller steps to find the optimal dose for each patient.”

“The launch of the new drinkable form of rufinamide in Germany and shortly in Austria will help to narrow the gap between the available treatments for LGS and the needs of children and young people with this severe form of epilepsy,” said Dr Andreas Mommertz, Brand Director, Eisai Germany.

“As a consequence, it could make LGS treatment more manageable, supporting compliance with treatment, one of the key factors in reducing seizure frequencies particularly for young people with severe epilepsy.”

Epilepsy treatment is a major strategic focus for Eisai in Europe.

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