Latigo Biotherapeutics Secures Fast Track Status for LTG-001 to Combat Acute Pain Without Opioids
Latigo Biotherapeutics has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LTG-001, a groundbreaking oral medication designed to manage acute pain without the use of opioids. This designation is significant as it accelerates the development and review of drugs aimed at addressing unmet medical needs. LTG-001 acts as a selective inhibitor of the Nav1.8 sodium channel, effectively targeting pain at its source by blocking peripheral sensory neurons responsible for transmitting pain signals to the nervous system.
In the Phase 1 clinical trial, LTG-001 demonstrated a favorable safety profile and tolerability with predictable pharmacokinetics. The trial involved 72 healthy participants and assessed the drug’s capacity to offer rapid pain relief. Remarkably, participants experienced a Tmax of approximately 1.5 hours, indicating that LTG-001 is absorbed quickly into the bloodstream, reinforcing its potential utility in both acute and chronic pain management.
Nima Farzan, the CEO of Latigo, expressed enthusiasm for receiving this designation, stating, "This marks an important milestone for Latigo and emphasizes the promise of LTG-001 as a well-tolerated, non-opioid treatment option for pain. With this Fast Track designation, we are eager to collaborate closely with the FDA to expedite the development process and make this essential medicine available to patients in need."
Dr. Neil Singla, the Chief Medical Officer at Latigo, pointed out the urgent demand for effective non-opioid treatments in the medical landscape. By receiving Fast Track designation, Latigo seeks to address a serious and widespread issue for patients suffering from acute pain conditions. This designation will provide Latigo with early and frequent communication opportunities with the FDA throughout the entire clinical development process. Furthermore, it allows the possibility of reviewing parts of the marketing application before the full application is approved.
Latigo Biotherapeutics is dedicated to developing innovative, non-opioid pain relief solutions that do not carry the risk of addiction. Funded by prominent investors, including Westlake Village BioPartners and 5AM Ventures, Latigo continues to strive towards its goal of offering quick-acting pain remedies that prioritize patient safety.
LTG-001’s development exemplifies how scientific advancements can lead to safer alternatives for pain management, marking a hopeful future in the treatment of painful conditions. As Latigo makes strides in the clinical trial phases, the biopharmaceutical industry watches closely to see how LTG-001 could transform the treatment landscape for millions grappling with pain-related ailments. For further information about LTG-001 and Latigo Biotherapeutics, interested parties can visit the company's website at www.latigobio.com and follow their updates on LinkedIn.
In the Phase 1 clinical trial, LTG-001 demonstrated a favorable safety profile and tolerability with predictable pharmacokinetics. The trial involved 72 healthy participants and assessed the drug’s capacity to offer rapid pain relief. Remarkably, participants experienced a Tmax of approximately 1.5 hours, indicating that LTG-001 is absorbed quickly into the bloodstream, reinforcing its potential utility in both acute and chronic pain management.
Nima Farzan, the CEO of Latigo, expressed enthusiasm for receiving this designation, stating, "This marks an important milestone for Latigo and emphasizes the promise of LTG-001 as a well-tolerated, non-opioid treatment option for pain. With this Fast Track designation, we are eager to collaborate closely with the FDA to expedite the development process and make this essential medicine available to patients in need."
Dr. Neil Singla, the Chief Medical Officer at Latigo, pointed out the urgent demand for effective non-opioid treatments in the medical landscape. By receiving Fast Track designation, Latigo seeks to address a serious and widespread issue for patients suffering from acute pain conditions. This designation will provide Latigo with early and frequent communication opportunities with the FDA throughout the entire clinical development process. Furthermore, it allows the possibility of reviewing parts of the marketing application before the full application is approved.
Latigo Biotherapeutics is dedicated to developing innovative, non-opioid pain relief solutions that do not carry the risk of addiction. Funded by prominent investors, including Westlake Village BioPartners and 5AM Ventures, Latigo continues to strive towards its goal of offering quick-acting pain remedies that prioritize patient safety.
LTG-001’s development exemplifies how scientific advancements can lead to safer alternatives for pain management, marking a hopeful future in the treatment of painful conditions. As Latigo makes strides in the clinical trial phases, the biopharmaceutical industry watches closely to see how LTG-001 could transform the treatment landscape for millions grappling with pain-related ailments. For further information about LTG-001 and Latigo Biotherapeutics, interested parties can visit the company's website at www.latigobio.com and follow their updates on LinkedIn.
Topics Health）
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