Fentanyl Citrate

The patches in question were manufactured by Kindeva Drug Delivery and distributed by Alvogen across the U.S. to pharmacies and patients. When it comes to the safe use of synthetic opioids like fentanyl, precise dosing of the powerful pain meds is key. Now, Alvogen is yanking one product in the U.S. thanks to a packaging error that's already yielded at least one major safety report. Alvogen has issued a voluntary recall on a single lot of fentanyl transdermal patches due to the risk that some of the products could be "multi-stacked" and stuck together in a single pouch.Patients who apply the stacked pouches run the risk of taking a higher dose than intended, potentially leading to serious, life-threatening or fatal breathing issues, Alvogen warned. First-time users of the patches, plus children and the elderly, are at greater risk of potential overdose incidents, the company added.So far, Alvogen says it has already received at least one "serious adverse event" report tied to the mispackaged products. The patches in question are used to manage severe and persistent pain in opioid-tolerant patients over an extended treatment period. The recall covers Lot 108319 of the transdermal patches, which were originally slated to expire in April 2027. The batch, containing cartons of five individually wrapped and labeled pouches, was manufactured by Kindeva Drug Delivery and distributed by Alvogen across the country to pharmacies and patients, according to a Jan. 31 press release.Alvogen is advising patients to immediately remove any patches in use and contact their healthcare providers. Unused patches should be returned to the point of purchase and swapped out for a replacement. The problem is not new to Alvogen, which recalled two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches in April 2019 after discovering that “a small number of cartons” labeled as 12 mcg/h actually contained 50 mcg/h patches. Those lots were manufactured by 3M Drug Delivery Systems in St. Paul, Minnesota.Elsewhere, Hikma last summer recalled one batch of acetaminophen injection, a pain med, citing the “potential presence” of a bag labeled dexmedetomidine HCL in the wrong packaging. 

Q3 2024 highlights › Total net revenues of SEK 136.5 m (156.1) › EBITDA of SEK -0.7 m (-9.5) › Net earnings of SEK -41.9 m (-33.3) › US Commercial segment net revenues of SEK 131.0 m (140.4), in local currency USD 12.6 m (13.0) › Cash flow from operating activities of SEK -13.4 m (-21.9), cash and cash equivalents of SEK 114.9 m (184.2) › Earnings per share before and after dilution amounted to SEK -1.21 (-0.97) › Orexo AB´s sustainability work ranked among the top five percent of all 70,000 businesses worldwide reviewed by EcoVadis › For OX124, our high dose naloxone rescue medication for opioid overdose, a complete response letter was received from the FDA requesting additional technical data on the final commercial product as well as further information from a new human factors study (HF study). A new HF study was successfully conducted in July. › The financial guidance for 2024 reiterated. Important events after the end of the period › An exploratory phase 1 clinical study was initiated for OX640 in participants with allergic rhinitis. A quarter of setbacks and achievements CEO Comments in brief The third quarter has been challenging, starting with the delay of OX124’s approval and, from a financial perspective, we had a marginally negative EBITDA. This negative EBITDA result was primarily due to higher legal costs, retrospective adjustments of the Abstral® royalties and lower Zubsolv® sales. The development was partly compensated by a 15 percent drop in expenses. Zubsolv prescription volumes in the US are stable, but sales were negatively impacted by a reduction in inventory levels at wholesalers and a weakening USD. Looking beyond the third quarter, I am pleased to see Zubsolv sales continuing to show stable demand and growth in some segments. We remain optimistic that we can get OX124, our high dose rescue medication for opioid overdose, approved and expand treatment alternatives for patients suffering from opioid use disorder. In the quarter we made progress in our business development efforts, attracting new companies to leverage our AmorphOX® technology, and we continue to see interest in OX640. Also, there are signs that we are making some progress to resolve the legal disputes in the US. Nikolaj Sørensen President and CEO For the full CEO comments view PDF Contact persons quarterly report Nikolaj Sørensen, President and CEO Fredrik Järrsten, EVP and CFO Lena Wange, IR & Communications Director Tel: +46 18 780 88 00, +1 855 982 7658, E-mail: ir@orexo.com. Presentation On October 24, at 2 pm CET analysts, investors and media are invited to attend a presentation, incl. a Q&A. To attend via teleconference where you can ask questions verbally: https://conference.financialhearings.com/teleconference/?id=50048738 When registered you will be provided phone numbers and a conference ID to access the conference. To attend via webcast: https://ir.financialhearings.com/orexo-q3-report-2024 Prior to the call, presentation material will be available on the website under Investors/ Report Archive This information is information that Orexo AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-10-24 08:00 CEST. Attachments Orexo Q3 2024 Interim Report