Attached files
| file | filename |
|---|---|
| EX-99.1 - EX-99.1 - SUPERNUS PHARMACEUTICALS, INC. | ex99112-22x2020.htm |
| 8-K - 8-K - SUPERNUS PHARMACEUTICALS, INC. | supn-20201222.htm |
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. 1 Supernus Pharmaceuticals SPN-812 Topline Results – ADHD Phase III Study in Adults (P306) December 2020 Exhibit 99.2
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include forward-looking statements within the meaning of the federal securities laws. These statements, among other things, relate to Supernus’ business strategy, goals and expectations concerning its product candidates, ability to integrate the acquired portfolio into its infrastructure, future operations, prospects, plans and objectives of management. The words “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict“, “project”, “will“, and similar terms and phrases are used to identify forward-looking statements in this presentation. Supernus’ operations involve risks and uncertainties, many of which are outside its control, including the potential impact of COVID-19, and any one of which, or a combination of which, could materially affect its results of operations and whether the forward-looking statements ultimately prove to be correct. Supernus assumes no obligation to update any forward-looking statements except as required by applicable law. Supernus has filed with the U.S. Securities and Exchange Commission (SEC) reports and other documents required by Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. Before you purchase any Supernus securities, you should read such reports and other documents to obtain more complete information about the company’s operations and business and the risks and uncertainties that it faces in implementing its business plan. You may get these documents for free by visiting EDGAR on the SEC website at http://www.sec.gov. 2
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. SPN-812 Phase III Adult Study P306 N = 374 Study Design ADHD Patients Adults Randomized, double-blind, two arm placebo-controlled study Starting dose of 200mg on week 1, 400mg on week 2, followed by flexible dosing between 200mg and 600mg per day. Daily Doses 200mg to 600mg Primary Endpoint Change from baseline to end of study on ADHD Investigator Symptom Rating Scale (AISRS) total score compared to placebo. 3
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. SPN-812 Phase III Adult Study: Fast Onset of Action Efficacy Starting as Early as Week 2 – Primary Endpoint Primary Endpoint Visit Statistics Placebo (N=179) 200mg to 600mg1 (N=175) Baseline Mean 37.6 38.5 Week 1 p-value 0.2941 Week 2 p-value 0.0397 Week 3 p-value 0.0005 Week 4 p-value 0.0014 Week 5 p-value * * Week 6 (EOS) LS Mean -11.7 -15.5 p-value 0.0040 4 Primary Analysis of AISRS. EOS = End of Study *Per study design, at Week 5 no patient visit was conducted, and no data were collected. 1 200mg on week 1, 400mg on week 2, followed by flexible dose administration to 600mg.
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. SPN-812 Phase III Adult Study: Fast Onset of Action Efficacy Starting as Early as Week 2 – Secondary Endpoint Clinical Global Impression - Severity Score (CGI-S) Visit Statistics Placebo (N=179) 200mg to 600mg1 (N=175) Baseline Mean 4.6 4.6 Week 1 p-value 0.1833 Week 2 p-value 0.0203 Week 3 p-value <0.0001 Week 4 p-value 0.0004 Week 5 p-value * * Week 6 (EOS) LS Mean -1.0 -1.4 p-value 0.0023 5 EOS = End of Study *Per study design, at Week 5 no patient visit was conducted, and no data were collected. 1 200mg on week 1, 400mg on week 2, followed by flexible dose administration to 600mg.
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. SPN-812 Phase III Adult Study Significant Reduction in Inattention Subscale Inattention Subscale Visit Statistics Placebo (N=179) 200mg to 600mg1 (N=175) Baseline Mean 21.1 21.5 Week 1 p-value 0.1127 Week 2 p-value 0.0113 Week 3 p-value 0.0003 Week 4 p-value 0.0006 Week 5 p-value * * Week 6 (EOS) LS Mean -6.1 -8.5 p-value 0.0015 6 EOS = End of Study *Per study design, at Week 5 no patient visit was conducted, and no data were collected. 1 200mg on week 1, 400mg on week 2, followed by flexible dose administration to 600mg.
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. SPN-812 Phase III Adult Study Significant Reduction in Hyperactivity/Impulsivity Subscale Hyperactivity/Impulsivity Subscale Visit Statistics Placebo (N=179) 200mg to 600mg1 (N=175) Baseline Mean 16.5 17.0 Week 1 p-value 0.9991 Week 2 p-value 0.3478 Week 3 p-value 0.0073 Week 4 p-value 0.0236 Week 5 p-value * * Week 6 (EOS) LS Mean -5.8 -7.2 p-value 0.0380 7 EOS = End of Study *Per study design, at Week 5 no patient visit was conducted, and no data were collected. 1 200mg on week 1, 400mg on week 2, followed by flexible dose administration to 600mg.
© 2020 Supernus Pharmaceuticals, Inc. All Rights Reserved. 8 AEs = Adverse Events SPN-812 Phase III Adult Study Summary of Treatment Related Adverse Events (Safety Population) Number (%) of Patients - Treatment Related AEs with ≥ 5% Incidence P306 Placebo (N=183) SPN-812 (N=189) Insomnia 9 (4.9) 43 (22.8) Fatigue 5 (2.7) 22 (11.6) Decreased appetite 4 (2.2) 19 (10.1) Nausea 4 (2.2) 19 (10.1) Headache 9 (4.9) 17 (9.0) Dry mouth 4 (2.2) 17 (9.0) Discontinuation due to AEs 9 (4.9) 17 (9.0)