loxapine oral / Generic mfg. - LARVOL DELTA

[VIRTUAL] Loxapine as an Alternative to Clozapine (APA 2021) - "Whereas medication compliance, psychotic symptoms, and agitation were managed very well on oral Loxapine, patients responded well due to the elimination of the side-effects such as sialorrhea, and the need for regular lab work for CBC monitoring. Several recent studies suggested Loxapine a drug of choice because of similarity with Clozapine in efficacy, more routes of administration, cost- effectiveness, and with better side-effect profile. It has superiority for immediate use as it provides a convenient route of administration through the inhalation route. Since psychiatric agitation and uncontrolled psychotic symptoms are major challenges in a psychiatric setting, psychiatrists and healthcare workers would find benefit from this unique option."

Agranulocytosis • Bipolar Disorder • CNS Disorders • Granulocytopenia • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Elite Pharmaceuticals Enters into an Exclusive Distribution Agreement with Prasco, LLC and Announces Commercial Launch of Loxapine Capsules (BioSpace) - "Elite entered a license, supply, and distribution agreement ('Agreement') with Prasco for Elite's Abbreviated New Drug Application (ANDA) for Loxapine Succinate capsules, 5 mg, 10 mg, 25 mg, and 50 mg ('Loxapine Capsules'). Loxapine is indicated for the treatment of schizophrenia and is currently listed on the FDA drug shortage list....'Elite is excited to partner with Prasco to launch Loxapine'..."

Generic launch • CNS Disorders • Schizophrenia

Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q2 2021 Results - Earnings Call Transcript (SeekingAlpha) - "Loxapine site transfer is already done and approved. We are waiting for API to launch. We expect to launch this product in Q1 of 2021 (sic). We have a marketing partner for Loxapine. And we are just awaiting as I said the API, it is coming from India and we're expecting it any day....Loxapine is currently on the FDA's product shortage list."

Generic launch • CNS Disorders • Schizophrenia

Inhaled Drug Therapy Development for the Treatment of Migraine. (PubMed) - Expert Opin Pharmacother - "Inhaled DHE offers rapid absorption with a pharmacokinetic profile similar to IV administration. Improved side effect profile results from more selective binding at anti-migraine serotonergic receptors 5-HT1B and 5-HT1D. Inhaled prochlorperazine is rapidly absorbed and resulted in statistically significant migraine pain relief at 2 hours compared to placebo but is not currently being pursued by the manufacturer as a potential migraine abortive. Inhaled loxapine is also rapidly absorbed into systemic circulation but Phase IIb trials did not show statistically improved pain relief or pain freedom compared to placebo. Inhaled therapy clearly offers rapid systemic absorption but this route of delivery may not be appropriate for every drug. MAP0004 will likely provide a good alternative to patients seeking rapid relief without the need for injection or other invasive routes."

Journal • Biosimilar • Migraine • Pain

Evaluation of inhaled loxapine treatment in psychiatric patients with acute agitation (ECNP 2017) - "(1) IL reduced initial agitation and showed a good adverse effects profile, therefore it could be ideally used as a rapid and noninvasive alternative route of administration in cooperative psychiatric patients with this kind of acute disorders. (2) However, even if the delivery system is innovative for an antipsychotic drug, it presumes that some kind of patient collaboration is undoubtedly required. Moreover, the drug-related risk of bronchospasm must always be kept in mind when planning to use inhaled loxapine, leading to a careful patient assessment prior to administration."

Clinical • Real-World Evidence • Addiction (Opioid and Alcohol) • Bipolar Disorder • CNS Disorders • Depression • Schizophrenia

30 drugs in short supply in the US right now (24/7 Wall St.) - "Loxapine...Shortage first reported: Nov. 25, 2019 Loxapine is an antipsychotic used to treat the symptoms of schizophrenia. The treatment reduces excessive excitement in the brain."

Commercial

Loxapine for Treatment of Patients With Refractory, Chemotherapy-Induced Neuropathic Pain: A Prematurely Terminated Pilot Study Showing Efficacy But Limited Tolerability. (PubMed, Front Pharmacol) - P2; "...Patients received loxapine orally as add-on analgesic in a dose-escalating manner (four treatment episodes for 14 days, daily dose: 20, 30, 40, or 60 mg loxapine) depending on tolerability and analgesic efficacy...However, loxapine is no valid treatment option for painful polyneuropathy due to profound dopamine and histamine receptor-related side effects. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02820519."

Clinical • Journal