For the second time this yr, the FDA has authorised a non-prescription naloxone nasal spray to counteract the consequences of opioid overdose. The most recent regulatory resolution is for a product from Hurt Discount Therapeutics.
Hurt Discount, a nonprofit pharmaceutical firm based in 2017, claims that not having a revenue motive permits it to concentrate on its mission of saving lives by making OTC naloxone out there totally free or on the lowest attainable value. The FDA approval now clears the way in which for Pittsburgh-based Hurt Discount to launch its product, which might be marketed beneath the title RiVive.
The FDA resolution for RiVive is predicated on information from a research that confirmed the nasal spray achieves related ranges within the blood as an authorised prescription naloxone product. Hurt Discount additionally supplied information displaying shoppers perceive learn how to use the drug safely and successfully with out steering from a clinician.
In line with the FDA, greater than 105,000 reported deadly overdoses occurred within the 12-month interval ending in February 2023. These overdoses had been primarily pushed by artificial opioids like illicit fentanyl, the company mentioned.
“We all know naloxone is a robust device to assist rapidly reverse the consequences of opioids throughout an overdose. Making certain naloxone is extensively out there, particularly as an authorised OTC product, makes a crucial device out there to assist shield public well being,” FDA Commissioner Robert Califf mentioned within the regulator’s announcement. “The company has lengthy prioritized entry to naloxone merchandise, and we welcome producers of different naloxone merchandise to debate potential nonprescription growth applications with the FDA.”
RiVive’s approval comes 4 months after the FDA authorised an OTC model of Narcan from Emergent BioSolutions, making that product the primary nasal spray naloxone product out there and not using a prescription. Emergent mentioned on the time it anticipated OTC Narcan would turn into out there by late summer season.
It’s been a busy week for regulatory developments within the U.S. and Europe. Right here’s a recap of some latest regulatory information highlights:
—Biohaven acquired an FDA refuse to file letter for troriluzole, an experimental remedy for spinocerebellar ataxia (SCA), a uncommon neuromuscular dysfunction with no authorised therapies. The drug failed its Section 3 research however a publish hoc evaluation confirmed extra encouraging leads to a subset of sufferers. Biohaven had sought approval for treating this subset of SCA sufferers. The FDA declined to overview the appliance. Biohaven mentioned it can request a gathering to debate the FDA’s considerations.
—Octapharma’s Balfaxar, a drug that reverses the consequences of the blood thinner warfarin, is now FDA authorised for treating sufferers present process surgical procedures. However scientific trial outcomes confirmed extra problems and deaths within the research drug group versus the comparator arm. Balfaxar’s approval comes with a black field warning and a post-marketing requirement for a scientific trial to additional assess the drug’s dangers.
—Gilead Sciences drug Trodelvy is now authorised in Europe for treating breast most cancers in sufferers whose illness is assessed as HR optimistic and HER2 damaging, which is the commonest sort of breast most cancers. The European Fee resolution covers sufferers who’ve acquired endocrine-based remedy and no less than two extra systemic therapies. The FDA authorised Trodelvy for this indication in February.
—AstraZeneca drug Soliris, whose authorised indications embrace the uncommon neuromuscular dysfunction generalized myasthenia gravis (gMG), is now authorised in Europe for treating that dysfunction in youngsters and adolescents. The antibody drug, developed by AstraZeneca uncommon illness subsidiary Alexion, is designed to dam C5, a complement system protein whose extreme exercise is related to some autoimmune issues.
—A drug that originally reached the marketplace for controlling fleas and ticks in canines and cats is now authorised for treating Demodex blepharitis, an inflammatory eye situation in people that’s attributable to infestation of mites. The Tarsus Prescribed drugs drug is an eye fixed drop formulation of the oral veterinary product lotilaner. Tarsus will market its new drug beneath the model title Xdemvy. FDA approval of the drug for Demodex blepharitis makes it the primary drug licensed for the attention indication.
—Mirum Prescribed drugs drug Livmarli is now authorised in Canada. The drug was developed to deal with the extreme itching symptom related to the uncommon liver illness Alagille syndrome. The FDA authorised Livmarli for treating Alagille syndrome sufferers in 2021.
—An anthrax vaccine developed by Emergent BioSolutions acquired FDA approval. Cyfendus was developed to forestall anthrax illness in adults 18 to 65 who’ve been uncovered to the pathogen. The 2-dose intramuscular injection is given alongside antibacterial medication. Emergent developed Cyfendus in partnership with the Biomedical Superior Analysis and Growth Authority. The vaccine joins an Emergent anthrax portfolio that features the BioThrax vaccine and two remedies, Anthrasil and raxibacumab.
—Daiichi Sankyo most cancers drug Vanflyta acquired FDA approval for treating acute myeloid leukemia (AML) together with chemotherapies. The approval additionally contains use of the drug as a upkeep monotherapy following consolidation chemotherapy. Vanflyta particularly treats AML sufferers whose illness reveals FLT3-ITD mutations. The FDA additionally authorised a companion diagnostic to establish this mutation in newly identified AML sufferers.
—The European Medicines Company’s Committee for Medicinal Merchandise for Human Use issued a damaging opinion on Krazati, a Mirati Therapeutics drug for superior non-small cell most cancers that carries a mutation referred to as KRAS G12C. In line with the corporate, the committee mentioned the drug has a optimistic risk-benefit profile, nevertheless it doesn’t fulfill sure necessities for a conditional advertising and marketing authorization. Mirati mentioned it disagrees with the opinion and can request a re-examination. Krazati acquired accelerated FDA approval final yr.
Picture: Getty Photos, Sarah Silbiger
