Caretek Medical has announced the selection of sumatriptan succinate as its lead drug compound at the Needle-Free and Auto Injector Conference in London
Sumatriptan is currently prescribed in tablet form to treat migraine, a common condition that affects around 12% of the UK population, and Caretek now plans to develop a solid form of the drug that will be suitable for patients to inject using the company's patented ImplaJect device.
The development should enable many thousands of migraine sufferers to enjoy fast, effective relief from their symptoms.
Migraine is treated with tablets or nasal sprays and when these do not work, or sufferers need faster relief, injections are used.
The market for the sole existing injectable migraine drug, a form of Sumatriptan that is known as Imigran in the UK and Imitrex in the USA and delivered via needle and syringe, was approximately $220 million in 2005.
In recent focus group discussions with Imigran users, the migraine sufferers showed enthusiasm for Caretek's needle-free device, which is easier to assemble, use and dispose of than their current medication, and could provide fast, reliable relief for their symptoms.
Focus groups of GPs have endorsed ImplaJect as an effective delivery system that is particularly suitable for home use by patients or carers with minimal training.
Charles Potter, Caretek's founder and chief executive officer, is also the inventor of ImplaJect.
Making the announcement, he said: "We have demonstrated that we can develop generic products such as Sumatriptan with much shorter development times than for new drugs".
"We hope to start clinical trials later this year with the objective of launching a new product that is suitable for use with ImplaJect onto the market in 2008." Andrew Dowson, director of the headache service at King's College, London, and chairman of the Migraine in Primary Care Advisor Group (Mipca), has helped Caretek to set up its work with focus groups.
Welcoming the announcement, Dr Dowson, said: "The development of Sumatriptan for use with the ImplaJect device could mark an important step forward in the treatment of migraine".
"Only 50% of migraine sufferers respond to existing over the counter treatments and, on prescription, needle and syringe devices are not widely used".
"ImplaJect is a much more user-friendly injectable option and does not carry the hazards of disposal and needle prick injuries associated with syringes".
"This new product could meet the significant unmet needs of a wide group of people, ranging from those who have not yet used triptan drugs to severe migraine sufferers who need the faster drug absorption time that injections can provide - Sumatriptan's speed of effect is 10 minutes after injection, compared with 30 minutes in tablet form".
"It can also enable GPs to deliver more individualised patient care." Caretek hopes that Sumatriptan will be the first of a range of solid form drugs developed for use with the ImplaJect device, and is exploring collaborations with pharmaceutical companies.
Dr Potter explained: "We undertook studies on a number of potential drug candidates before selecting Sumatriptan as a first product to focus on and develop for use with ImplaJect".
"However, there is huge potential to develop other products - many drugs, such as insulin, vaccines and emergency pain relief, cannot be administered by mouth because they will not be adequately absorbed in the body or will not act quickly enough so they are delivered in liquid form via needle and syringe".
"This is an uncomfortable process that carries a risk of infection as well as the significant costs of cool storage of liquid drugs and needle disposal - a major issue as 15 billion needles are used worldwide every year".
"ImplaJect could provide a user-friendly and cost-effective alternative method to deliver many protein-based drugs in solid form".
"We are interested in exploring partnering opportunities to co-develop the technology for both generic and proprietary medicines."
