AstraZeneca has announced results of a study showing that the safety profile of Symbicort budesonide/formoterol inhalation aerosol 320/9 µg twice daily was similar to that for a budesonide alone pMDI 320 µg twice daily in African-American patients with moderate-to-severe asthma. The data from the 52-week randomized, double-blind Phase IIIb safety study were published … [Read more...] about Study shows equivalent safety for Symbicort compared to budesonide alone in African Americans
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AANMA announces winners of Innovations in Technology awards
The non-profit patient education organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has announced the winners of its 2012 Top Ten Innovations in Technology Awards for "products and services that have meaningfully improved quality of life for people with allergies, asthma and related conditions." Of the ten winners, seven are OINDPs. AANMA Founder … [Read more...] about AANMA announces winners of Innovations in Technology awards
Melbourn Scientific adds Freeman Technology powder characterization capability
Melbourn Scientific is now offering powder characterization services using the Freeman Technology FT4 Powder Rheometer to optimize formulation and analysis services for inhaled drug and device development. Melbourn Scientific Operations Director Derek Solomon commented, “A key challenge of developing pharmaceuticals for inhalation is creating a formulation that … [Read more...] about Melbourn Scientific adds Freeman Technology powder characterization capability
Positive Phase 2 results for nasal spray to treat binge eating disorder
Lightlake Therapeutics has announced preliminary results from a Phase 2 trial of its intranasal naloxone for the treatment of patients with binge eating disorder. According to the company, the randomized, double-blind, placebo-controlled trial demonstrated that patients using the naloxone nasal spray spent a significantly smaller amount of time binge eating than did … [Read more...] about Positive Phase 2 results for nasal spray to treat binge eating disorder
Sunovion to launch Zetonna ciclesonide nasal aerosol in the US by Fall 2012
Sunovion has announced that it will make its Zetonna ciclesonide nasal aerosol for the treatment of allergic rhinitis available in the US in time for the fall allergy season. The FDA approved Zetonna, an HFA formulation delivered by nasal pMDI, in January 2012. Sunovion markets two other ciclesonide aerosols in the US: Omnaris nasal spray for the treatment of … [Read more...] about Sunovion to launch Zetonna ciclesonide nasal aerosol in the US by Fall 2012
FDA lifts clinical hold on Arikace inhaled liposomal amikacin
According to Insmed, the FDA has lifted the clinical hold placed on Arikace liposomal amikacin for inhalation for the treatment of pseudomonas lung infections in cystic fibrosis patients in July 2011. A hold on Arikace for non-tuberculous mycobacteria (NTM) lung disease was lifted in January of this year. Insmed says that it has reached an agreement with the FDA … [Read more...] about FDA lifts clinical hold on Arikace inhaled liposomal amikacin
Alexza gets complete response letter for Adasuve
The FDA has issued a complete response letter to Alexza Pharmaceuticals regarding its New Drug Application (NDA) for Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The FDA had previously extended the review period after Alexza submitted an updated proposed Risk Evaluation and Mitigation … [Read more...] about Alexza gets complete response letter for Adasuve
FDA approves Meda’s Dymista nasal spray, warns company on Astepro script
According to Meda, the FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. Meda filed the NDA approximately one year ago, in April 2011. Meda CEO Anders Lonner said, "Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work … [Read more...] about FDA approves Meda’s Dymista nasal spray, warns company on Astepro script
Paper compares multi-component particles to mixed powders for inhaled combination therapies
A review paper published in the Spring 2012 issue of European Respiratory Disease contends that, "Drug delivery to lungs with a consistent and predesigned ratio of co-associated active components can help maximise the chance of co-location at the active site and hence increases the potential of synergistic action from the solid." Authored by Dipesh Parikh, David … [Read more...] about Paper compares multi-component particles to mixed powders for inhaled combination therapies
Upsher-Smith recruiting for Phase 3 study of midazolam nasal spray
Upsher-Smith Laboratories is recruiting patients aged 14-65 with partial or generalized epilepsy who experience seizure clusters for an ongoing Phase 3 clinical trial called ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray). As part of the recruiting effort, the company has launched a website, www.seizureclusterstudy.com. Upsher-Smith is … [Read more...] about Upsher-Smith recruiting for Phase 3 study of midazolam nasal spray