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Hikma Pharmaceuticals PLC (Hikma) is a multinational pharmaceutical company headquartered in the UK, with a global presence across North America, the Middle East and North Africa (MENA), and Europe. With over 45 years of experience, Hikma focuses on creating high-quality medicines and making them accessible to millions of people. The company transforms cutting-edge science into innovative solutions that improve people's lives. Hikma is committed to providing a broad range of branded and non-branded generic medicines, shaping a healthier world for all communities. Through collaborations, partnerships, and ventures, Hikma is at the forefront of advancing precision medicine and healthcare technologies globally.
Hikma Pharmaceuticals has announced an exclusive six-year commercial partnership with Emergent BioSolutions for the sale of KLOXXADO® (naloxone HCl nasal spray 8 mg) in the U.S. and Canada. KLOXXADO® received FDA approval in April 2021 for emergency treatment of suspected opioid overdose in adults and pediatric patients.
Under the agreement, Emergent will incorporate KLOXXADO® into its naloxone product portfolio and handle all North American sales and marketing. Hikma will continue manufacturing the 8 mg naloxone HCl nasal spray at its Columbus, Ohio facility as the exclusive supplier to Emergent. The partnership combines Hikma's manufacturing capabilities with Emergent's established commercial expertise in naloxone nasal spray distribution.
Hikma will maintain production and marketing of its other naloxone products, including injectable vials and prefilled syringes, ensuring wide accessibility to healthcare providers and the public health community.
Hikma Pharmaceuticals participated in a naloxone training event with U.S. Congressman Buddy Carter ahead of National Fentanyl Awareness and Prevention Day. The event, held at Groves High School in Savannah, Georgia, marks Hikma's milestone of donating over 600,000 doses of naloxone in the past three years. Hikma is working with government officials and the White House Office of National Drug Control Policy to expand access to naloxone, a vital tool for reversing overdoses.
Hikma manufactures multiple forms of naloxone, including generic injectable vials, prefilled syringes, and KLOXXADO® (naloxone 8mg) intranasal spray. The company's Hikma Community Health initiative partners with frontline organizations to expand naloxone access through donations, partnerships, and awareness programs. Hikma also provides a Co-Pay Assistance Program for KLOXXADO® to increase accessibility and reduce out-of-pocket costs.
Hikma Pharmaceuticals PLC announces the shelf-life extension of KLOXXADO® (naloxone HCl) nasal spray 8mg from 24 to 36 months. This change applies to products manufactured from March 2024 onwards. KLOXXADO® contains twice the naloxone dose of Narcan® Nasal Spray 4mg, offering a important treatment option for opioid overdose reversal.
The extended shelf-life is particularly beneficial for frontline responders and individuals carrying KLOXXADO® for emergency use. This development comes as organizations like the CDC and American Medical Association note that higher doses of naloxone may be necessary to counteract poisoning from illicit fentanyl and other synthetic opioids. Hikma emphasizes its role in combating the opioid crisis, especially as International Overdose Awareness Day approaches on August 31st.
Hikma Pharmaceuticals and Glenmark Specialty announced the US launch of RYALTRIS™, a nasal spray for treating seasonal allergic rhinitis (SAR), approved by the FDA for patients aged 12 and older. This combination therapy relieves nasal and ocular symptoms, offering onset relief in 15 minutes. With 60 million Americans affected by allergic rhinitis, this product addresses a significant unmet need, particularly as many patients report inadequate symptom control. Hikma aims to expand its specialty business in the US through this launch, utilizing its existing salesforce to reach healthcare providers.