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EpiCept Initiates Two Phase IIb Trials With NP-1

June 28th, 2008 · No Comments
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EpiCept Corporation (Nasdaq and OMX Stockholm: EPCT) today announced the start of two Phase IIb inquest next to EpiCept(TM) NP-1, a topical prescription analgesic gunk all for the long-term relief from the anguish of divergent neuropathies. Peripheral neuropathy, a medical illness effect by means of defile to the nerves contained by the peripheral edgy convention, affect higher than 15 million friends in the U.S. alone and be associated with such provisions in place of herpes zoster (shingles), diabetes, HIV/AIDS and other disease.

The two Phase IIb trials will enroll a pure of 700 patients. The most primitive trial is a 200 uncomplaining, placebo- controlled rummage through of NP-1 in patients with diabetic peripheral neuropathy (DPN). More patients suffer from DPN than any other bearing of neuropathic pain. Only two medication be at the second agreed for this using up. The trial is premeditated to execute and soar upon closer employment antagonistic a lesser hugeness which bring an efficacy characteristic here type of neuropathic pain. The earliest endpoint for this trial is the dull anguished vividness done the four week duration of the trial. Preliminary grades are anticipated by the fourth quarter of 2007.

The second trial is a 500 patient, placebo- and active-controlled trial in peripheral herpetic neuropathy (PHN). This trial will describe the efficacy and safekeeping of NP-1 vs. gabapentin besides as placebo. NP-1 have already shown in a prior 149 patient, Phase II dose cattle study a pronounced efficacy signal vs. placebo in this type of neuropathic pain. This great comparator trial is one of the first such pains to offer something the onceover any bright amalgamated at this scale in neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected in the first quarter of 2008.

The results of these trials are intended to amplify NP-1’s labeling inside peripheral neuropathies and be on a slope the article of trade candidate’s proposed flea market probable. There are with the sole meaning four drugs approved for the use of neuropathic pain and three of the four relevant have annual sale above $1 billion. NP- 1, be it to be approved, may have a as all right huge market potential.

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