“Our strategic shift in focus away from opioids and to pharmaceutical-grade cannabinoids and novel drug delivery systems continues to gain momentum and has been driven by our strong commitment to advancing our diverse product pipeline,” said
STRATEGIC ALTERNATIVE REVIEW UPDATE
INSYS previously announced plans to begin a strategic alternative review of its opioid-related assets and the process remains on schedule. Nine companies have signed confidential disclosure agreements and have begun a review of confidential information materials. The company will provide an update on the process during the fourth quarter 2018 earnings call in early 2019.
INSYS anticipates that it will have a number of critical interim steps and proof points across its diverse product portfolio over the next several months. This includes two potentially life-saving investigational products using its spray technology that are in advanced stages of clinical development: a) naloxone nasal spray for opioid overdose, and b) epinephrine nasal spray for anaphylaxis. It also includes clinical development efforts focused on cannabinoids: a) CBD oral solution as an investigational treatment for childhood absence epilepsy (Phase 2), b) infantile spasms (Phase 3), c) Prader-Willi Syndrome (Phase 2); and, d) dronabinol inhalation as a potential treatment for a variety of conditions, including anorexia in cancer. The following information updates important upcoming milestones for each of these innovative molecules and novel drug delivery systems.
Results of a pharmacokinetic (PK) study reported in early November showed a distinctive profile for the company’s naloxone nasal spray product candidate in comparison to the current standards, including intramuscular (IM) injection. INSYS believes that the characteristics of its drug hold particular relevance in the context of rising rates of overdose from highly potent synthetic opioids, as standard doses of currently approved naloxone products may not be sufficient due to the drug’s relatively short half-life.
INSYS is currently completing a required nonclinical juvenile toxicity study related to naloxone, which has been fully enrolled, and expects the results of that program in early March of 2019. Pending positive results from that study, the current target timeframe for NDA submission remains around the end of the first quarter of 2019.
As a needle-free delivery method, INSYS’ epinephrine nasal spray represents a potential alternative to intramuscular injection. As reported in
Given clinical and regulatory progress to date, INSYS believes the epinephrine NDA remains on track for filing during the fourth quarter of 2019, pending successful completion of a confirmatory PK study and no additional clinical studies requested by the
Also of note, data from the product candidate’s clinical development program will be presented at the
All three trials with CBD oral solution are enrolling patients, including a Phase 2 study of childhood absence epilepsy, a Phase 3 study of infantile spasms, and a Phase 2 study of Prader-Willi syndrome.
- The company expects to show initial results from the Phase 2 trial in childhood absence epilepsy late in the first quarter 2019 as the company continues to enroll patients.
- Results of the long-term safety study of CBD in refractory pediatric epilepsy were reported on
Dec. 3at the American Epilepsy Society2018 annual meeting and showed that the company’s proprietary formulation of the drug was generally well-tolerated, even at high doses, through 48 weeks of follow up.
- The company is continuing to enroll patients in a Phase 2 study of Prader-Willi Syndrome across seven clinical sites with a plan to add additional sites in 2019. The company expects full results of this study in the second half of 2019.
- Enrollment in the company’s Phase 3 study of infantile spasms has occurred at a slower pace than anticipated, and the company will provide an update once it has better visibility into enrollment.
Additionally, the company is committed to supporting three studies planned by the
Lastly, alternative oral-dose formulations of CBD are in early development. With results from nonclinical studies expected in the first quarter, the next phase of development, including clinical trials targeting additional chronic indications, is scheduled to commence in the latter part of 2019.
Regarding dronabinol inhalation, which successfully completed the initial human proof-of-concept study in
This news release contains forward-looking statements based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the
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|Jackie Marcus or Chris Hodges|
|Alpha IR Group|
Source: INSYS Therapeutics, Inc.