The FDA has approved Hospira, Inc.’s (HSP) proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic, Dyloject. The drug is approved for use in adults for the management of mild-to-moderate pain as well as moderate-to-severe pain.
The drug can be used alone or in combination with opioid analgesics. Dyloject is not a replacement for opioids. Dyloject can be administered within 15 seconds compared to a 15 to 30 minutes full dose administration of other injectable non-opioid analgesics.
Results from two double-blind, placebo and active-controlled, multiple-dose studies on Dyloject showed that the drug successfully reduced pain intensity.
However, the Dyloject indication comes with a boxed warning indicating risks of serious cardiovascular and gastrointestinal events associated with Dyloject use.
We note that Dyloject became a part of Hospira’s portfolio through the acquisition of Javelin Pharmaceuticals in 2010.
Our Take
We are encouraged by the approval of Dyloject which will bring quick relief to patients suffering from moderate-to-severe and mild-to-moderate pain because of its faster administration procedure. The approval strengthens Hospira’s existing acute-care drugs portfolio.
However, the boxed warning in the drug’s indication could limit sales once launched.
Meanwhile, Endo International (ENDP) also has several painkillers in its portfolio like Lidoderm and Opana ER.
Hospira carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Affymetrix Inc. (AFFX) and AMAG Pharmaceuticals, Inc. (AMAG). Both stocks carry a Zacks Rank #1 (Strong Buy).
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