SUN PHARMA’s Post

Thanks to Moe Alsumidaie for his interview with Alex Greg Sturmer, CEO of Elysium Therapeutics, Inc., which was featured in The Clinical Trial Vanguard. Elysium is an emerging biopharmaceutical company that is establishing new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead SMART opioid product candidate – oral-overdose protected (O2P™) hydrocodone – is being developed for the treatment of moderate-to-severe acute pain. Elysium is also developing its SMART rescue medicine, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. https://lnkd.in/eGqSwPSM

Ten years of hard work has finally come to fruition! 🚀   We are pleased to report positive topline data for the phase 2b trial of EMP16, our oral therapy for treating obesity. 💊   Participants in the trial demonstrated up to 23% in weight loss, bringing our long-term weight management therapy one step closer to the market.    With an established safety and tolerability profile, EMP16 offers a solution for long-term weight management. Unlike other therapies currently on the market, patients can take it for long periods to help manage their weight.   We’re now ready to initiate phase 3 clinical trials and are looking for partnerships or investments to bring EMP16 to FDA and EMA markets in 2027.   We spoke to Endpoints News about the trial and our hopes to commence our pivotal trials later this year.   Read our interview here 👇 https://lnkd.in/d3B_B45Z   #Obesity #DrugDevelopment #ClinicalTrials

Phase 1/2 clinical trial of #SPG302 for the treatment of people with #Amyotrophic Lateral Sclerosis (#ALS). The trial will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of product candidate dosed as a once-a-day pill in ALS patients. #Spirogenix #FDA #HiRO #Innovation

Know this clinical pearl to avoid conflict if you’re about to order a drug screen for a patient on Butrans. 📌: https://lnkd.in/eJQbRwr4 As the use of buprenorphine for pain management grows, understanding how to interpret urine drug screens for buprenorphine becomes increasingly important. Butrans, a low dose transdermal buprenorphine formulation, doesn’t always show up positive in urine drug tests. In fact, nearly 1/3 of patients on Butrans in a study didn’t have high enough drug levels to be detected by confirmatory test, which is considered the gold standard for drug screening. So, if a drug test comes back negative for a patient on Butrans, it’s crucial to interpret the result carefully—considering clinical improvement, PDMP, and trust. ——————— 💊 Daily Pain Dose: What do we know about Belbuca then? #PainManagement #Opioids #OpioidStewardship

Did you know? There are lots of new drugs under development that are inching their way through the pipeline to one day become available to us to try! https://lnkd.in/gWT_UZxb Check out our Dry Eye Drug Pipeline page to see: -Who's recently submitted FDA approval paperwork? -Who's getting ready to submit? -How many new drugs are currently undergoing human clinical trials? If you ever feel discouraged about the future of dry eye treatment, lists like this can give you a window into the vast research and development going on towards better solutions that will work for more of us. While drugs are not the only pathway to improving life with dry eye disease, drug development remains an important source of hope for our community. #dryeye #optometry #ophthalmology #arvo2024 #dryeyedisease #dryeyezone

The FDA advisory committee tasked with scrutinizing donanemab has unanimously endorsed this investigational medication for Alzheimer’s, developed by Eli Lilly. This is excellent news for patients with Alzheimer’s, as the drug could be fully approved by the FDA by summer 2024. We are proud to have contributed to the clinical development of this promising medication. More importantly, we are overjoyed for patients worldwide who struggle with cognitive impairments. With full approval, donanemab will join ranks with Leqembi as the second symptom-modifying medication on the market. This is yet another hope-giving option for patients and another weapon in the fight against Alzheimer’s. Such moments are why we do what we do. For further reading, check out the full story here: [USA Today - FDA Alzheimer’s Drug Donanemab](https://lnkd.in/g8AwCWuN) #AlzheimersResearch #ClinicalTrials #Donanemab #HopeForPatients #SyrentisClinicalResearch #EliLilly #MedicalBreakthroughs #FightAlzheimers

What is the best injection for weight loss based on clinical trials result in shorter period of time? The only FDA approved weight loss injections are Wegovy, Saxenda, and Zepbound. Based on current studies, Wegovy and Zepbound show optimal results. According to some studies, Zepbound (tirzepatide) and Wegovy (semaglutide) by Eli Lilly and Company are among the best weight loss injections: Zepbound In a head-to-head study, patients taking the highest dose of Zepbound lost around 21% of their body weight over 72 weeks, compared to around 15% for patients on Wegovy after 68 weeks. Zepbound works on both GLP-1 and GIP receptors, which may contribute to its greater weight loss benefits. Wegovy A 2022 literature review found that Wegovy was more effective for weight loss than placebo and other antidiabetic medications. In a 68-week study, people receiving Wegovy lost an average of roughly 16% of their initial body weight, compared to about 6% in the Saxenda group. MariTide In a phase 1 study, three doses of MariTide helped people lose up to nearly 15% of their initial body weight after 3 months of use. Results persisted for 5 months after their last dose. #HealthCare #Pharmacy #Diabetes #T2D #WeightManagement #ClinicalTrials #FDA #Tirzepatide #Zepbound #Semaglutide #Wegovy #EliLilly #Maritide

Pain, essentially is a natural experience with evolutional significance. Pain relief is not just a removal of an emotional stimulus with negative valance but also functions as the behavioral manifestation of the neurobiological basis of reward and reinforcement. A drug may not be able to show “pain relief” if it’s restrictedly functioning at peripheral region. As a “peripherally restricted” candidate, you can not have it both ways, safety vs potency: peripheral vs central. A pain relief drug is much more than an analgesic.

#BiolinkCapital, a global licensing platform under #ClinicalServiceCenter, offering high quality licensing-out & licensing-in services for drug development programs. #BiolinkAssetInformation: ILP100-INN emilimogene sigulatibac– #Lactobacillus expressing human #CXCL12 Indications: 1)Treatment of non-healing wounds in people with #diabetes； 2)Treatment of surgical wounds in patients with #prediabetes, diabetes and #obesity； 3)Other indications possible. -Status: Phase 2 clinical developments ongoing EU (CTA) and US (IND) -Collaboration Opportunities: license takeover, co-development. -Highlights: • Extensive RCT phase 1 trial concludes clean safety and 10 days faster time to complete wound healing. • Antimicrobial and kills multi drug resistant (MDR) bacteria. #BiolinkLicensingService #BiolinkLicensingProducts

In the latest CDER Conversation, OGD's Liang Zhao and OTS's Mehul Mehta discuss how CDER helps ensure the dosage range of narrow therapeutic index drugs falls within a safe and effective therapeutic window for patients: https://lnkd.in/eHeHkxz2