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FDA to Revisit Opioid Labeling for Chronic Pain
Bloomberg Television· 2025-07-11 16:03
Talk to us about opioids that the FDA failed. The FDA did fail. There were many parts of our health care system that failed.Look, I feel terrible about the opioid epidemic. I personally prescribed opioids with misinformation. It was taught to me by my chief resident in my surgical residency, and we sort of woke up to this problem around 2014, 2015 and thought, Oh my God, what have we done.What information did we not have. I think was regulatory capture at the agency. Now we can't prove that.But when the rev ...
Emergent BioSolutions Expands NARCANDirect® to Offer KLOXXADO® (naloxone HCl) Nasal Spray 8 mg and Convenience Kits Amid Changes in Overdose Death Rate
Globenewswire· 2025-07-02 20:05
Core Insights - Emergent BioSolutions is expanding its NARCANDirect online distribution network to include KLOXXADO Nasal Spray 8 mg, enhancing access to opioid overdose response tools starting July 1, 2025 [1][2] - The addition of KLOXXADO Nasal Spray, a higher dose naloxone product, aims to provide more options for emergency responders and communities in addressing opioid emergencies [2][4] - Recent CDC data indicates a 27% decrease in drug overdose deaths in 2024, with opioid-related deaths dropping by 34%, although a subsequent increase in overdose deaths was reported, highlighting the ongoing need for effective response tools [3][4] Company Developments - Emergent acquired exclusive commercial rights to KLOXXADO Nasal Spray in January 2025, aiming to increase the availability of naloxone in the U.S. and Canada [2] - The company is also introducing Convenience Kits through NARCANDirect, which will include essential components for overdose response, such as a CPR mask and examination gloves [4] - Emergent emphasizes the importance of collaboration with various sectors to enhance community preparedness for opioid emergencies [4] Industry Context - The opioid crisis remains a significant public health challenge, necessitating continuous innovation and support in overdose response strategies [3][4] - The introduction of KLOXXADO Nasal Spray is part of a broader effort to combat the evolving nature of the opioid epidemic and improve emergency preparedness [3][4]
Emergent BioSolutions Supports Victoria's Voice Foundation's National Naloxone Awareness Day Efforts on June 6 to Encourage Americans to Be Prepared for Opioid Emergencies
GlobeNewswire News Room· 2025-06-05 11:00
Continued commitment to reducing the number of opioid overdose deaths by expanding access, increasing awareness and educating the public about life-saving naloxone GAITHERSBURG, Md., June 05, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) is teaming up with Victoria's Voice Foundation to rally Americans to help save lives from the opioid epidemic on National Naloxone Awareness Day, which honors the late Victoria Siegel and others who have succumbed to overdose. As part of the effort, Victor ...
Emergent BioSolutions Reinforces Commitment to Opioid Emergency Preparedness Efforts in Canada Through Multi-Year Contract with Ontario Ministry of Health
Globenewswire· 2025-05-01 21:07
Core Points - Emergent BioSolutions Inc. has entered a three-year agreement valued at approximately $65 million to supply NARCAN Nasal Spray to the Ontario Ministry of Health for the Ontario Naloxone Program [1] - The agreement aims to enhance access to NARCAN Nasal Spray, which is critical for reversing opioid overdoses, especially given the ongoing opioid crisis in Ontario [2][3] Company Overview - Emergent BioSolutions has been supplying NARCAN Nasal Spray to Ontario since 2018, demonstrating a long-term commitment to addressing opioid poisoning deaths in Canada [1][3] - The company emphasizes the importance of making life-saving medications available to individuals at risk of opioid overdose and their communities [3][4] Industry Context - From January to March 2025, Ontario reported 653 suspected drug-related fatalities, averaging 7 deaths per day, although there was a 30% decrease in overdose deaths compared to the same period in the previous year [2] - The Ontario Naloxone Program is crucial for providing access to naloxone, a life-saving medication, to those at risk of opioid overdose [4]
Polyrizon Initiates Preclinical Studies for Intranasal Naloxone Targeting Opioid Overdose Based on Its Innovative T&T Platform
Globenewswire· 2025-03-10 11:47
Core Viewpoint - Polyrizon Ltd. has initiated preclinical studies for intranasal Naloxone, aiming to enhance opioid overdose treatment through its innovative Trap and Target™ platform [1][3][4] Company Overview - Polyrizon is a development stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [6] - The company is advancing its proprietary Capture and Contain (C&C) hydrogel technology and the Trap and Target (T&T) platform for nasal delivery of active pharmaceutical ingredients [6] Industry Context - The opioid crisis is a global public health emergency, with a significant rise in overdose fatalities driven by synthetic opioids like fentanyl [4] - The global Naloxone market is projected to reach $2.47 billion by 2032, growing at a CAGR of 11%, while the intranasal Naloxone spray market is expected to reach $1.4 billion by 2030 [4] Research and Development - The preclinical studies will evaluate key parameters such as drug loading capacity, release kinetics, nasal deposition, and stability, which are essential for further safety and efficacy testing [3] - The T&T platform is designed to optimize drug delivery, potentially enhancing the bioavailability and effectiveness of intranasal Naloxone [4]