Elite Pharmaceuticals Inc (OTCMKTS:ELTP) confirmed the launch of its generic Hydroxyzine HCI tablets through Epic Pharma LLC. It is a private Pharma company based in Laurelton, NY. The tablets are meant for symptomatic relief of tension and anxiety related with certain disease states. It even helps in the management of pruritus arising due to certain allergic conditions.
The market
As per IMS Health Data, the annual sales for Hydroxyzine HCI tablets in the U.S. are measured around $40 million for the year ended June 30, 2014. Epic Pharma will produce, package and distribute Hydroxyzine under the Manufacturing and License Deal previously finalized between Elite Pharmaceuticals and Elite.
The details
Elite confirmed that dosing was concluded for two trials to support ELI-200 labeling. The two studies were the fed trial and the withdrawal effects trial. The first trial is a Phase 1, randomized, single-dose, open-label and three-way crossover trial to assess the bioavailability of ELI-200 product compared to the reference product as per fed conditions in healthy enrollments. The second study is a safety trial and will be a randomized, double-blind, parallel group and multiple-dose study to assess the potential withdrawal effects after administration of ELI-200 compared to the reference product given to opioid-dependent enrollments.
The plans
Nasrat Hakim, the President and CEO said that Hydroxyzine HCI is another generic tablet launched under the license deal with Epic. The company continues to expand its product range of generic medication. He added that the management is delighted with the completed dosing in the two trials of the ELI-200 as requested by the U.S. FDA. The company looks forward to start the third study soon and report results in the coming period.
In last trading session, the stock price of Elite declined 0.22% to close the trading session at $0.225. The decline came at a share volume of 428,103 much lower than average share volume of 1.12 million.
