Hikma Pharmaceuticals plc (LON:HIK) (NASDAQ Dubai:HIK) (OTC:HKMPY) announced on Thursday the approval of KLOXXADO (naloxone HCl) Nasal Spray 8 mg by Health Canada for treating opioid overdoses in adult patients.
The nasal spray delivers 8 mg of naloxone hydrochloride per dose to reverse opioid overdose effects, such as respiratory and central nervous system depression.
Under a six-year commercial agreement, Emergent BioSolutions Inc (NASDAQ:EBS) will lead the marketing and sales of KLOXXADO in Canada, where it aims to increase access to intranasal naloxone. Emergent will work with Canadian agencies and private payers to make KLOXXADO available by prescription as early as 2026.
Hikma will continue to manufacture KLOXXADO at its Columbus, Ohio facility and supply it exclusively to Emergent for commercialisation. The approval of KLOXXADO Nasal Spray comes at a time when Health Canada has reported a decrease in overdose deaths, partly attributed to expanded naloxone distribution.
Hikma announces Health Canada approval of KLOXXADO Nasal Spray for opioid overdose treatment
Plus Therapeutics secures FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda
Latigo Biotherapeutics' LTG-001 receives US FDA Fast Track designation
GenSight Biologics reports positive five-year resultsfor LUMEVOQ gene therapy
Bain Capital to acquire Mitsubishi Tanabe Pharma in USD3.3bn deal
Innovent and ASK Pharm's limertinib NDA receives Chinese regulatory approval
Anavex reports positive long-term data for blarcamesine in early Alzheimer's disease
Johnson & Johnson agrees acquisition of Intra-Cellular Therapies Inc
Neuraxpharm acquires Provigil and Nuvigil to expand CNS portfolio
Nuvation Bio secures NMPA approval for taletrectinib in China
JCR Pharmaceuticals and Modalis Therapeutics advance to next phase of joint gene therapy research
PTC Therapeutics submits vatiquinone NDA to US FDA
Mitsubishi Tanabe Pharma forms research collaboration with Dewpoint Therapeutics
IXICO signs commercial agreement with PETNET Solutions to enhance neuroimaging capabilities