OINDP companies get together to create new event series

Led by inhaler device platform designer and supplier Merxin and by Nanopharm, a CRO specializing in inhaled and nasal drugs, a group of companies that offer products and services for OINDP development has come together to put on a new event series called Inspire Me. The first event will take place on June 4 and 5, 2019 in San Francisco, CA, USA, with the first day devoted to dry powder inhalers and the second day to soft mist inhalers.

The companies, which represent a comprehensive range of expertise in OINDP technology, also include filling and packaging company Harro Höfliger; DPI capsule and spray drying experts Lonza (Capsugel); particle analysis specialists Malvern Panalytical; lactose manufacturer Meggle; human factors researchers MedHF; generic device developer, and spray analysis experts Proveris Scientific.

Merxin Chief Business Officer Philippe Rogueda explains the reasoning behind creating the new event: “InspireMe events are meant to be educational, to teach people how to make inhaler products from API to registration. This sort of overview and product building is sometimes taught at university by non-practitioners, but not in main stream conferences by industrialists with a wealth of experience. This event aims to teach how to make inhalers from a purely industrial perspective: from the best in the industry with current live experience.”

“Soft-mist and dry powder inhalers are emerging as the preferred delivery system by offering several benefits, such as, non-invasive, propellant free, easy to handle, easy to operate, and gradual release profile,” adds Ben Okorodudu, VP of Sales for Proveris Scientific; “However, the variations in design, formulation, and use present significant challenges in the development, and manufacturing of a successful drug products. A focused conference that delves into the challenges, and opportunities for DPI, and SMI creates a platform for addressing relevant science, technology, and tools for achieving safe, effective, commercially viable respiratory drug delivery.”

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UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA

UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.

NAYZILAM® (midazolam) nasal spray* is a nasally administered benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.

NAYZILAM allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure cluster occurs.

Approval of NAYZILAM adds to UCB’s already existing anti-epilepsy drug portfolio, reinforcing the company’s position as a global leader in epilepsy.

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FDA approves first generic naloxone nasal spray to treat opioid overdose

Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths, increase access to emergency treatment

The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.

“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”

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Positive Pilot Phase 3 Data Position VistaGen’s PH94B Neuroactive Nasal Spray for Pivotal Phase 3 Development as a Novel, As-Needed Treatment for Social Anxiety Disorder

VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for depression, social anxiety disorder and other central nervous system (CNS) diseases and disorders with high unmet need, announced today additional results from a positive pilot Phase 3 study of PH94B, a potential first-in-class neuroactive nasal spray shown to be effective on an as-needed (PRN) basis for treatment of social anxiety disorder (SAD). The new data were presented in a poster session at the 2019 Anxiety and Depression Association of America (ADAA) Annual Conference in Chicago.

About PH94B Neuroactive Nasal Spray: PH94B neuroactive nasal spray is fundamentally different from all current treatments for SAD. Developed from proprietary compounds called pherines and administered as a nasal spray, PH94B activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety. Its novel mechanism of pharmacological action, rapid-onset of therapeutic effects and exceptional safety and tolerability profile shown in clinical trials to date make PH94B neuroactive nasal spray an excellent product candidate with potential to become the first FDA-approved PRN treatment for SAD.

In a published double-blind, placebo-controlled Phase 2 clinical trial, PH94B neuroactive nasal spray was significantly more effective than placebo in reducing public-speaking and social interaction anxiety on laboratory challenges of individuals with SAD.2.

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Opiant Pharmaceuticals Announces Award

Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, has been awarded the second tranche of $3.0 million from the total grant of approximately $7.4 million from the National Institutes of Health’s (“NIH”) National Institute on Drug Abuse (“NIDA”) for the development of OPNT003, nasal nalmefene, a long-acting opioid antagonist for the treatment of opioid overdose.

Based on feedback from the U.S. Food and Drug Administration, Opiant intends to pursue a 505(b)(2) development path and anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in 2020.

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OtiTopic Moves towards Its Clinical Phase with Dry Powder Inhalation of Aspirin to Reduce the Risk of Vascular Mortality in Patients with Suspected Acute Myocardial Infarction (Ml)

OTITOPIC™ is an early stage pharmaceutical, privately funded drug development company with a track record of success in Pharmaceutical product drug delivery and drug device development. ASPRIHALE™ is a proprietary Dry Powder Inhalation of aspirin formulation delivered via portable dry powder inhaler (DPI) that is expected to enter the bloodstream faster than oral tablets at the time of MI. OTITOPIC™ is on track with ASPRIHALE™ to file an NDA for a novel drug-device combination product in rescue management of suspected acute myocardial infarction (MI). OTITOPIC™ is committed to providing high-risk MI patients with a faster alternative for management of suspected myocardial infarction (MI).

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FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”

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FDA issues new and revised product specific guidances for five nasal sprays

The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019.

According to the agency, the latest batch of guidances issued includes a total of 74 drugs, with 49 of those being complex drugs. FDA Commissioner Scott Gottlieb said, “As the FDA works to help promote drug competition and patient access to affordable medicines, our efforts have been especially focused on complex drugs, which may be harder to genericize and often face less competition. In 2019, the agency will continue to advance policies to help promote competition in this space and help to reduce development time for complex generics.”

Guidances for mometasone furoate, fluticasone propionate and azelastine HCL/fluticasone propionate were issued in 2015. The previous guidance for triamcinonolone acetonide nasal spray was released in 2016.

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Read the FDA announcement.
View the guidance on DHE nasal spray.
View the guidance on fluticasone propionate nasal spray.
View the guidance on azelastine hydrochloride/fluticasone propionate nasal spray.
View the guidance on mometasone furoate nasal spray.
View the guidance on triamcinolone acetonide nasal spray.

ARS Pharmaceuticals Announces FDA Fast Track Designation for ARS-1 Intranasal Epinephrine Spray

ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ARS-1, an investigational intranasal epinephrine spray that could provide an easy-to-use, convenient and more reliable treatment for severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

“The FDA’s decision to grant Fast Track Designation for our novel intranasal epinephrine spray is an important milestone in our mission to deliver a reliable needle-free treatment option that is easier to carry and use for the emergency treatment of severe allergic reactions that could lead to anaphylaxis,” said Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals. “Fast Track Designation is an acknowledgement from the FDA of the potential contribution of our low dose intranasal epinephrine product for patients and caregivers, and we look forward to advancing the development of ARS-1 so it is available to the community as soon as possible.”

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FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression

If approved, SPRAVATO™ will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) that data support the favorable benefit-risk profile of SPRAVATOTM (esketamine) nasal spray CIII for adults living with treatment-resistant depression. SPRAVATOTM is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder (MDD). Janssen announced on September 4, 2018 that it submitted a New Drug Application (NDA) to the FDA for the approval of SPRAVATOTM.1 If approved, SPRAVATOTM would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.

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