If, as expected, the European Commission accepts the recommendation of its Committee for Medicinal Products for Human Use (CHMP), it would be the second major approval of duloxetine hydrochloride (sold in the US as Cymbalta) for the management of diabetic peripheral neuropathic pain (DPNP), following the September 2004 approval by the FDA.
The drug has also been approved as safe and effective for other major medical conditions in Europe – under the name Yentreve – for the treatment of moderate-to-severe stress urinary incontinence, and as Cymbalta, for the treatment of major depressive episodes.
Although it does not change the underlying nerve damage caused by diabetic peripheral neuropathy, Cymbalta does help relieve the burning, stabbing and shooting pain that is the hallmark of this condition. Furthermore, Cymbalta is not a controlled substance, unlike some other medications used to manage DPNP.
The CHMP, which comprises regulators from the 25 European Union countries, based its positive opinion on its review of the comprehensive data package that included, in part, data from two randomized fixed-dose studies.
In both studies, duloxetine significantly reduced 24-hour average pain, compared with placebo. Improvements were noted as early as the first week of treatment and continued for the duration of the studies. In addition, duloxetine showed rapid onset of action and effect in reducing pain caused by diabetic neuropathy at both 60mg per day and 120mg per day, and was effective in relieving pain at night.
Following the CHMP’s positive opinion for duloxetine for diabetic peripheral neuropathic pain, the European Commission is expected to grant marketing authorization within the next few months.