Hikma Pharmaceuticals PLC (LON:HIK) said the US Food and Drug Administration (FDA) has approved Kloxxado, its emergency treatment of known or suspected opioid overdose.
It can be used on adult and paediatric patients and contains twice as much naloxone per spray as the commonly used Narcan. It is administered in a ready-to-use nasal spray.
Drug overdose, including most commonly opioid overdose, has been described as the "leading cause of accidental death" in the US today, the pharma company said, and the situation has been exacerbated by the COVID-19 pandemic.
It added that, according to health organizations, widely prescribing and distributing naloxone may play a vital role in the fight against opioid overdose.
Kloxxado will be available in the second half of 2021.
In a separate announcement, Hikma said that current trading is in line with expectations and full-year outlook remains unchanged.
The injectables business is performing well and full-year revenue in this segment is forecast to rise 5-6% with core operating margin of 37-38%.
The generics arm is also doing well, with continued demand for COVID-19 related products and good performance from recent launches.
The group has resumed the launch of generic Advair Diskus after the FDA approved a change to the application.
Revenue in the segment will be at the top end of guidance of US$770-810mln with core operating margin of 20%.
At the annual general meeting last week, shareholders approved a 2020 final dividend of 34 cents per share, bringing the total dividend to 50 cents per share, an increase of 14% on 2019.
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