Elite introduces generic hydroxyzine tablets

The tablets are indicated for symptomatic relief of anxiety and tension associated with certain disease states and management of pruritus due to certain allergic conditions.

Epic will be responsible for manufacturing, packaging and distributing the product as part of its manufacturing and license agreement with Elite.

According to IMS Health Data, annual US sales for immediate release Hydroxyzine HCI 10mg and 25mg and 50mg tablets are about $40m for the twelve months ending 30 June 2014.

Elite has also completed dosing for two studies to support ELI-200 product labeling – the fed study and the withdrawal effects study.

First was an open-label, randomized, single-dose, three-way crossover Phase I trial designed to compare the bioavailability of ELI-200 to the reference product under fed conditions in healthy volunteers.

The second study, a safety study, is a randomized, double-blind, multiple-dose, parallel group trial to evaluate the potential withdrawal effects following administration of ELI-200 versus the reference product in methadone-maintained opioid-dependent subjects.

The company said that a multi-center, randomized, multiple-dose, blinded, placebo-controlled, parallel group Phase III efficacy study is scheduled to begin dosing this quarter.

Around 165 patients at five clinical sites will be enrolled in this trial which will evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery.

Elite president and CEO Nasrat Hakim said: "I am also pleased to have completed dosing for two of the ELI-200 studies requested by the FDA and we look forward to initiating the third study and reporting results in the coming months. We continue to plan for an ELI-200 filing this year."