Zolpimist (zolpidem oral spray) / Arovella Therap, Aytu BioPharma - LARVOL DELTA

Enhancing Memory Consolidation in Older Adults (clinicaltrials.gov) - P4 | N=10 | Terminated | Sponsor: University of California, Irvine | The new lab was not adequately equipped to handle the sleep research and it was too far from the main lab. Funding was running out.

Enrollment change • Trial termination

Drugs for chronic insomnia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Insomnia • Sleep Disorder

Expanded table: Some oral drugs for chronic insomnia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Insomnia • Sleep Disorder

Emerging Treatments for Disorders of Consciousness in Paediatric Age. (PubMed, Brain Sci) - "However, long-known pharmacological therapies such as amantadine and zolpidem, as well as novel instrumental approaches using direct current stimulation and, more recently, stem cell transplantation, are applied in the absence of large paediatric clinical trials and rigorous age-balanced and dose-escalated validations...For patients with a poor prospect of recovery, withdrawal of care is inhomogeneous across countries and still heavily conditioned by treatment costs as well as ethical and cultural factors, rather than reliant on protocols for assessment and standardised treatments. In summary, there is a strong call for multicentric, international, and global health initiatives on DoC to devote resources to the paediatric age, as there is now scope for funders to invest in themes specific to DoC affecting the early years of the life course."

Journal • Bone Marrow Transplantation • CNS Disorders • Critical care • Infectious Disease • Pediatrics • Transplantation • Vascular Neurology

SUDA Pharmaceuticals (ASX:SUD) has insomnia treatment approved in Chile (The Market Herald) - "SUDA Pharmaceuticals (SUD) has had its lead product, ZolpiMist, for short-term insomnia in adults, approved by the Chile Ministry of Health....The company also noted approval was granted significantly sooner than the expected date of April 2022....SUDA Pharmaceuticals was up 2.04 per cent, trading at 5 cents at 2:20 pm AEDT."

Non-US regulatory • CNS Disorders • Insomnia • Sleep Disorder

SUDA Pharmaceuticals (ASX:SUD) signs distribution deal for sleep spray (The Market Herald) - "SUDA Pharmaceuticals (SUD) has entered an exclusive licence and distribution agreement for ZolpiMist in Australia. The agreement was signed with STADA Pharmaceuticals Australia...Under the agreement, SUDA will receive an upfront fee of $170,000 plus a milestone payment of $40,000. SUDA will also gain a 10 per cent royalty, based on net sales of ZolpiMist, which it will manufacture and supply at an agreed price....Clinical data has demonstrated a faster onset of action using ZolpiMist over conventional tablet forms of the drug, a critical factor for an effective anti-insomnia medication."

Licensing / partnership • CNS Disorders • Insomnia • Sleep Disorder

Effect of Zolpidem Tartrate on the Developmental Rate of Forensically Important Flies Chrysomya megacephala (Diptera: Calliphoridae) and Chrysomya saffranea. (PubMed, J Med Entomol) - "The morphological parameters and development rate for all life cycle stages of treated insects were determined and used to estimate postmortem intervals. Results showed that the morphological parameters, i.e., weight, width, and length and rate of development of C. megacephala and C. saffranea was negatively associated with zolpidem tartrate concentration of C. saffranea, were negatively associated with the concentration of zolpidem tartrate, indicating that arthropod evidence evaluation can help establish the cause and time of death."

Journal • Mood Disorders • Psychiatry • Sleep Disorder

SUDA Pharmaceuticals (ASX:SUD) shares drop as MTPS leaves ZolpiMist agreement (The Market Herald) - "SUDA Pharmaceuticals...shares are down this morning after Mitsubishi Tanabe Pharma Singapore (MTPS) announced it would not proceed with its ZolpiMist agreement....MTPS has opted to back out of the deal as it changes its business strategy across the Association of Southeast Asian Nations (ASEAN) region. Notably, SUDA says the termination of the agreement has no immediate impact on its revenue streams. The company says it will now focus on the remaining partnerships it has in place for ZolpiMist and will look on securing new partners for the ASEAN region."

Licensing / partnership • CNS Disorders • Insomnia • Sleep Disorder

Dr Boreham’s Crucible: Is Suda back on track after securing first TGA approval? (Stockhead) - "The Therapeutic Goods Administration’s green light means that not only can Suda sell Zolpimist in Australia, but it can use the assent to leverage approvals elsewhere....'A major focus for Suda is selecting the Australian partner to commercialise it,” he says. 'That’s not something we are taking lightly. We want the right partner.'..That leaves Suda’s own commercial focus on signing a local distributor for Zolpimist."

Commercial • CNS Disorders • Insomnia • Sleep Disorder

"@biospace USA feature: SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist https://t.co/yyzW7v3XYZ $SUD #ASX #OralSpray $SUD.AX" (@SudaPharmaLtd)

SUDA Reaches Major Milestone with Grant of TGA Approval for ZolpiMistTM, Stock Rallies Above 150% (Kalkine Media) - "SUDA Pharmaceuticals Limited...soared above 150 per cent to $0.068 on ASX on 29 July 2020, following the announcement regarding grant of Therapeutics Goods Administration’s (TGA) approval for ZolpiMistTM (zolpidem tartrate)....SUDA notified in its latest update that the TGA has approved the registration of ZolpiMistTM for the treatment of short-term insomnia in adults. While the completion of TGA review was expected in Q4 2020, the Company has achieved the approval ahead of its projected deadline."

Non-US regulatory • Stock price • Sleep Disorder

SUDA Pharmaceuticals will continue advancing oro-mucosal strategy with "constant energy" (Proactiveinvestors) - "In a letter to shareholders, Baker highlighted the company’s progress in advancing partnerships with pharmaceutical companies to reformulate products...'Recent clinical data demonstrates that for the treatment of insomnia, ZolpiMist works more efficiently than the tablet form of the drug, an important factor when considering the value proposition of an effective treatment.' "

Clinical data • Sleep Disorder

SUDA Pharmaceuticals gets coverage from Edison with 13 cents per share valuation (Proactiveinvestors) - "SUDA Pharmaceuticals Ltd...is focused on reformulating established drugs into oro-mucosal spray formulations for better bioavailability....Edison Investment Research has initiated coverage on SUDA at a valuation of $18 million or 13 cents per basic share (9 cents per diluted share) using a risk-adjusted NPV model focusing strictly on the ZolpiMist program. The research house attributes a 70% chance of success to ZolpiMist as it has already been approved in the US by the FDA..."

Financing • Sleep Disorder

SUDA Pharmaceuticals (ASX:SUD) plans to raise $3.56M entitlement offer (The Market Herald) - "SUDA Pharmaceuticals hopes to raise roughly $3.56 million through a one-for-one non-renounceable entitlement offer. Over 142.2 million shares will be issued at 2.5 cents each. SUDA will use the money to develop its...ZolpiMist spray, which treats insomnia."

Financing • Sleep Disorder

SUDA Pharmaceuticals to continue focus on cancer, insomnia treatments (Proactiveinvestors) - "The company is also continuing to progress its short-term insomnia treatment, ZolpiMist, for which it is expecting to hear an outcome from its TGA submission in the fourth quarter of 2020....SUDA was in a position to be able to announce the proposed transaction and capital raising when the company was expected to come out of the trading halt on June 3, 2020."

Financing • Non-US regulatory • Sleep Disorder

SUDA Pharmaceuticals submits additional data to TGA for ZolpiMist oral spray for insomnia (Proactiveinvestors) - "Suda Pharmaceuticals Ltd...has submitted additional data to the Therapeutic Goods Administration (TGA) for its ZolpiMistTM oral spray for the treatment of insomnia. SUDA submitted a Marketing Authorisation Application (MAA) to the TGA for ZolpiMist in April 2019....This new data supports the quality of product generated using the new API supplier and manufacturer..."

Non-US regulatory • CNS Disorders • Psychiatry • Sleep Disorder

SUDA Pharmaceuticals progresses Zolpimist commercialisation strategy (Proactiveinvestors) - "...the company continued to advance discussions with prospective partners for ZolpiMist for other territories....Cash receipts for the quarter were $323,000 with a bank balance at March 31 of $1.508 million....The company’s aim going forwards is to create additional partnerships to roll the ZolpiMist™ product out globally and it is waiting on regulatory approval from the Therapeutic Goods Administration to license the product in Australia."

Financing • Licensing / partnership • Non-US regulatory • CNS Disorders • Psychiatry • Sleep Disorder

Mitsubishi Tanabe Pharma Korea to market Australian insomnia treatment (Korea Biomedical Review) - "Mitsubishi Tanabe Pharma Korea said that it would import and market Zolpimist, an insomnia treatment, in Korea. Suda, a pharmaceutical company based in Australia, is the manufacturer of Zolpimist....'We are delighted to be able to supply a more convenient and quick-acting oral spray formulation of insomnia treatment to local insomnia patients through the agreement with Suda,' Mitsubishi Tanabe Pharma Korea President Narihiko Yoshii said."

Licensing / partnership