Nasal spray approved for opioid overdose
The FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, indicated for emergency treatment of suspected or known opioid overdose manifested by respiratory or central nervous system depression. Prior to this approval, naloxone hydrochloride, an opioid antagonist, was only approved in injectable forms, most commonly delivered by syringe or autoinjections.
Many first responders and primary caregivers have hoped for a nasal spray formulation of naloxone because it is easier to deliver and eliminates the risk of a contaminated needle stick. Prior to this recent approval, unapproved use of naloxone kits was widespread, which combined an injectable formulation of naloxone with an atomizer that delivered naloxone nasally.
Naloxone hydrochloride nasal spray does not require assembly. When used as directed, it delivers a consistent, measured dose. This prescription product can be used on adults or children and is easily administered, even by those without medical training. The drug is sprayed into one nostril while the patient lies on his or her back and can be repeated if necessary. It is important to note, however, that naloxone hydrochloride nasal spray is not a substitute for immediate medical care, and the individual administering naloxone hydrochloride nasal spray should seek further immediate medical attention on the patient's behalf.
In clinical trials of naloxone hydrochloride nasal spray, administering the drug in one nostril delivered approximately the same levels (or higher) of naloxone hydrochloride as a single dose of an FDA-approved naloxone hydrochloride I.M. injection and achieved these levels in approximately the same time frame.
FDA clears new combo inhaler for COPD
A new inhaled combination bronchodilator, indacaterol and glycopyrrolate (Utibron Neohaler), has been approved for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). The new drug combines the long-acting beta2-adrenergic agonist indacaterol and the long-acting anticholinergic glycopyrrolate, which is taken twice daily using the Neohaler device. The drug is not indicated for asthma treatment or for acute bronchospasm.
In two 12-week efficacy studies, indacaterol and glycopyrrolate showed superior and sustained improvements in lung function at week 12 compared with its individual bronchodilator components in addition to placebo. Improvements in lung function were seen compared with placebo at 5 minutes after the first dose and sustained through the 12-hour dosing interval. Nasopharyngitis, hypertension, and back pain were the most common adverse reactions reported in the efficacy studies.
First seasonal influenza vaccine with adjuvant approved
The FDA has approved the Influenza Vaccine Adjuvanted (Fluad), a new seasonal influenza vaccine containing adjuvant that is designed to provoke a stronger immune response in older adults. Fluad is the first seasonal flu vaccine that contains an adjuvant that enhances or directs the immune response of the vaccinated patient. The adjuvant is an oil-in-water emulsion of squalene oil, a naturally occurring substance in humans, animals, and plants that is highly purified for making vaccines. Fluad is a trivalent vaccine produced from two subtype A and a type B influenza strains. It is indicated specifically for adults age 65 and older.
The safety of Fluad has been evaluated in two studies. In the first, approximately 27,000 adults age 65 and older received the vaccine. The most common adverse reactions were injection site reaction, muscle aches, fatigue, and headache. In the second study, the immunogenicity of Fluad was compared with that of another trivalent influenza vaccine in approximately 7,000 adults age 65 or older. The antibody responses were similar between the two groups. The vaccine is contraindicated in patients who are allergic to the influenza vaccine and egg protein.